{
"NDC": [
{
"NDCCode": "80638-151-70",
"PackageDescription": "250 mL in 1 POUCH (80638-151-70) ",
"NDC11Code": "80638-0151-70",
"ProductNDC": "80638-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Frescosal Alcohol Wipes",
"NonProprietaryName": "70% Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200918",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FRESH CO COSMETICS SH.P.K.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200918",
"SamplePackage": "N",
"IndicationAndUsage": "Sanitizes and decreases bacteria on skin."
},
{
"NDCCode": "12546-151-70",
"PackageDescription": "70 LOZENGE in 1 BAG (12546-151-70) ",
"NDC11Code": "12546-0151-70",
"ProductNDC": "12546-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Breezers",
"ProprietaryNameSuffix": "Cool Berry",
"NonProprietaryName": "Pectin",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20190324",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Mondelez Global LLC",
"SubstanceName": "PECTIN",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190324",
"SamplePackage": "N",
"IndicationAndUsage": "<temporarily relieves the following symptoms associated with sore mouth and sore throat: 1 minor discomfort, 2 irritated areas>."
},
{
"NDCCode": "59726-151-70",
"PackageDescription": "3 CAN in 1 PACKAGE (59726-151-70) / 60 g in 1 CAN",
"NDC11Code": "59726-0151-70",
"ProductNDC": "59726-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208092",
"LabelerName": "P & L Development, LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240701",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)."
},
{
"NDCCode": "80638-260-48",
"PackageDescription": "260 mL in 1 POUCH (80638-260-48) ",
"NDC11Code": "80638-0260-48",
"ProductNDC": "80638-260",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "70%alcohol Wet Wipes",
"NonProprietaryName": "Antibacterial Antiseptic Wet Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "FRESH CO COSMETICS SH.P.K",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201101",
"SamplePackage": "N",
"IndicationAndUsage": "Sanitize and decreases bacteria on skin."
},
{
"NDCCode": "21130-151-01",
"PackageDescription": "59 mL in 1 BOTTLE (21130-151-01) ",
"NDC11Code": "21130-0151-01",
"ProductNDC": "21130-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Advanced Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Better Living Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin that could cause disease. Recommended for repeaed use."
},
{
"NDCCode": "21130-151-02",
"PackageDescription": "236 mL in 1 BOTTLE (21130-151-02) ",
"NDC11Code": "21130-0151-02",
"ProductNDC": "21130-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Advanced Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Better Living Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin that could cause disease. Recommended for repeaed use."
},
{
"NDCCode": "21130-151-03",
"PackageDescription": "473 mL in 1 BOTTLE (21130-151-03) ",
"NDC11Code": "21130-0151-03",
"ProductNDC": "21130-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Advanced Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Better Living Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin that could cause disease. Recommended for repeaed use."
},
{
"NDCCode": "21130-151-04",
"PackageDescription": "946 mL in 1 BOTTLE (21130-151-04) ",
"NDC11Code": "21130-0151-04",
"ProductNDC": "21130-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Advanced Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Better Living Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin that could cause disease. Recommended for repeaed use."
},
{
"NDCCode": "42361-151-01",
"PackageDescription": "1 TUBE in 1 CARTON (42361-151-01) > 50 g in 1 TUBE",
"NDC11Code": "42361-0151-01",
"ProductNDC": "42361-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ac Care Bees Shield Bb",
"ProprietaryNameSuffix": "Broad Spectrum Spf 35",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "DongSung Pharm Co., Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE",
"StrengthNumber": "44.1; 19.6; 70",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2021-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N"
},
{
"NDCCode": "50594-151-19",
"PackageDescription": "184 g in 1 BOTTLE, SPRAY (50594-151-19) ",
"NDC11Code": "50594-0151-19",
"ProductNDC": "50594-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Big Lots Soundbody Spf 70 Sun Defense",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191114",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BIG LOTS STORES, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "300; 1500; 500; 400; 600",
"StrengthUnit": "mg/10g; mg/10g; mg/10g; mg/10g; mg/10g",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191114",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "51346-151-01",
"PackageDescription": "30 mL in 1 CARTON (51346-151-01)",
"NDC11Code": "51346-0151-01",
"ProductNDC": "51346-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Snail Therapy 70 Eye",
"NonProprietaryName": "Glycerin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "6",
"StrengthUnit": "g/30mL",
"Status": "Deprecated",
"LastUpdate": "2018-08-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "56136-151-01",
"PackageDescription": "30 mL in 1 BOTTLE (56136-151-01) ",
"NDC11Code": "56136-0151-01",
"ProductNDC": "56136-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrating Mist Hand Sanitizer With Silicone Keychain Holder - Signature Scent",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Ganzhou Olivee Cosmetic Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Decrease bacteria on hands."
},
{
"NDCCode": "58503-151-01",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (58503-151-01) > 53 mL in 1 BOTTLE",
"NDC11Code": "58503-0151-01",
"ProductNDC": "58503-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer With Clip",
"ProprietaryNameSuffix": "1.8oz",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "China Ningbo Shangge Technology Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin. recommended for repeated use."
},
{
"NDCCode": "60951-602-70",
"PackageDescription": "100 TABLET in 1 BOTTLE (60951-602-70) ",
"NDC11Code": "60951-0602-70",
"ProductNDC": "60951-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Endocet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000526",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000526",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"IndicationAndUsage": "ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "60951-700-70",
"PackageDescription": "100 TABLET in 1 BOTTLE (60951-700-70) ",
"NDC11Code": "60951-0700-70",
"ProductNDC": "60951-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Endocet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030306",
"EndMarketingDate": "20280531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030306",
"EndMarketingDatePackage": "20280531",
"SamplePackage": "N",
"IndicationAndUsage": "ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "60951-701-70",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (60951-701-70) ",
"NDC11Code": "60951-0701-70",
"ProductNDC": "60951-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Endocet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030306",
"EndMarketingDate": "20280331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030306",
"EndMarketingDatePackage": "20280331",
"SamplePackage": "N",
"IndicationAndUsage": "ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "60951-712-70",
"PackageDescription": "100 TABLET in 1 BOTTLE (60951-712-70) ",
"NDC11Code": "60951-0712-70",
"ProductNDC": "60951-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Endocet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030306",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030306",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "62654-151-64",
"PackageDescription": "236 mL in 1 BOTTLE (62654-151-64) ",
"NDC11Code": "62654-0151-64",
"ProductNDC": "62654-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermacen Lotionized Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240807",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Central Solutions Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240807",
"SamplePackage": "N",
"IndicationAndUsage": "An effective antimicrobial hand cleanser for topical application. Recommended for repeated use. Reduces transient microorganisms on intact skin. Keeps hands from drying out due to repeated uses."
},
{
"NDCCode": "63481-623-70",
"PackageDescription": "100 TABLET in 1 BOTTLE (63481-623-70) ",
"NDC11Code": "63481-0623-70",
"ProductNDC": "63481-623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Percocet",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990630",
"SamplePackage": "N",
"IndicationAndUsage": "PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including PERCOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "63481-627-70",
"PackageDescription": "100 TABLET in 1 BOTTLE (63481-627-70) ",
"NDC11Code": "63481-0627-70",
"ProductNDC": "63481-627",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Percocet",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990630",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990630",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use:Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS], reserve PERCOCET for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 Have not been tolerated or are not expected to be tolerated.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg*(*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.)Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg*(*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.)Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg*(*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.)Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg*(*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.)Acetaminophen, USP 325 mg. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "63481-628-70",
"PackageDescription": "100 TABLET in 1 BOTTLE (63481-628-70) ",
"NDC11Code": "63481-0628-70",
"ProductNDC": "63481-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Percocet",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20011130",
"SamplePackage": "N",
"IndicationAndUsage": "PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including PERCOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "63481-629-70",
"PackageDescription": "100 TABLET in 1 BOTTLE (63481-629-70) ",
"NDC11Code": "63481-0629-70",
"ProductNDC": "63481-629",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Percocet",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20011130",
"SamplePackage": "N",
"IndicationAndUsage": "PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including PERCOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "65145-151-10",
"PackageDescription": "2 TRAY in 1 CARTON (65145-151-10) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65145-151-05) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-151-01) ",
"NDC11Code": "65145-0151-10",
"ProductNDC": "65145-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219212",
"LabelerName": "Caplin Steriles Limited",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250426",
"SamplePackage": "N",
"IndicationAndUsage": "Phytonadione injectable emulsion is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.Phytonadione injectable emulsion is indicated in: 1 anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;, 2 prophylaxis and therapy of hemorrhagic disease of the newborn;, 3 hypoprothrombinemia due to antibacterial therapy;, 4 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;, 5 other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Phytonadione injectable emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione USP, 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 4.5 to 7.0. Phytonadione is oxygen sensitive."
},
{
"NDCCode": "70108-151-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (70108-151-01) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "70108-0151-01",
"ProductNDC": "70108-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Vanilla Sugar Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250505",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ashtel Studios, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250505",
"SamplePackage": "N",
"IndicationAndUsage": "Decreases bacteria on skin."
},
{
"NDCCode": "70108-151-02",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (70108-151-02) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "70108-0151-02",
"ProductNDC": "70108-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Vanilla Sugar Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250505",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ashtel Studios, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Decreases bacteria on skin."
},
{
"NDCCode": "77357-151-01",
"PackageDescription": "125 mL in 1 BOTTLE (77357-151-01) ",
"NDC11Code": "77357-0151-01",
"ProductNDC": "77357-151",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Desmoldantes y Aditivos, S.A. de C.V.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "80638-150-12",
"PackageDescription": "590 mL in 1 POUCH (80638-150-12) ",
"NDC11Code": "80638-0150-12",
"ProductNDC": "80638-150",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Antiseptic Wet Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200918",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FRESH CO COSMETICS SH.P.K.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200918",
"SamplePackage": "N",
"IndicationAndUsage": "Decrease bacteria on skin. For use when soap and water are not available."
},
{
"NDCCode": "80638-150-48",
"PackageDescription": "290 mL in 1 POUCH (80638-150-48) ",
"NDC11Code": "80638-0150-48",
"ProductNDC": "80638-150",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Antiseptic Wet Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200918",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FRESH CO COSMETICS SH.P.K.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200918",
"SamplePackage": "N",
"IndicationAndUsage": "Decrease bacteria on skin. For use when soap and water are not available."
},
{
"NDCCode": "80638-600-01",
"PackageDescription": "600 mL in 1 POUCH (80638-600-01) ",
"NDC11Code": "80638-0600-01",
"ProductNDC": "80638-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Antiseptic Wet Wipes",
"NonProprietaryName": "Antibacterial Antiseptic Wet Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "FRESH CO COSMETICS SH. P.K.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201101",
"SamplePackage": "N",
"IndicationAndUsage": "DECREASES BACTERIA ON SKIN FOR USE WHEN SOAP AND WATER NOT AVAILABLE."
},
{
"NDCCode": "0054-0650-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0650-25) ",
"NDC11Code": "00054-0650-25",
"ProductNDC": "0054-0650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215138",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 300; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220509",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>80638-151-70</NDCCode>
<PackageDescription>250 mL in 1 POUCH (80638-151-70) </PackageDescription>
<NDC11Code>80638-0151-70</NDC11Code>
<ProductNDC>80638-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Frescosal Alcohol Wipes</ProprietaryName>
<NonProprietaryName>70% Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200918</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>FRESH CO COSMETICS SH.P.K.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sanitizes and decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12546-151-70</NDCCode>
<PackageDescription>70 LOZENGE in 1 BAG (12546-151-70) </PackageDescription>
<NDC11Code>12546-0151-70</NDC11Code>
<ProductNDC>12546-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Breezers</ProprietaryName>
<ProprietaryNameSuffix>Cool Berry</ProprietaryNameSuffix>
<NonProprietaryName>Pectin</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Mondelez Global LLC</LabelerName>
<SubstanceName>PECTIN</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage><temporarily relieves the following symptoms associated with sore mouth and sore throat: 1 minor discomfort, 2 irritated areas>.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59726-151-70</NDCCode>
<PackageDescription>3 CAN in 1 PACKAGE (59726-151-70) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>59726-0151-70</NDC11Code>
<ProductNDC>59726-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208092</ApplicationNumber>
<LabelerName>P & L Development, LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80638-260-48</NDCCode>
<PackageDescription>260 mL in 1 POUCH (80638-260-48) </PackageDescription>
<NDC11Code>80638-0260-48</NDC11Code>
<ProductNDC>80638-260</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>70%alcohol Wet Wipes</ProprietaryName>
<NonProprietaryName>Antibacterial Antiseptic Wet Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>FRESH CO COSMETICS SH.P.K</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sanitize and decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-151-01</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (21130-151-01) </PackageDescription>
<NDC11Code>21130-0151-01</NDC11Code>
<ProductNDC>21130-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Better Living Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin that could cause disease. Recommended for repeaed use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-151-02</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (21130-151-02) </PackageDescription>
<NDC11Code>21130-0151-02</NDC11Code>
<ProductNDC>21130-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Better Living Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin that could cause disease. Recommended for repeaed use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-151-03</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (21130-151-03) </PackageDescription>
<NDC11Code>21130-0151-03</NDC11Code>
<ProductNDC>21130-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Better Living Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin that could cause disease. Recommended for repeaed use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-151-04</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE (21130-151-04) </PackageDescription>
<NDC11Code>21130-0151-04</NDC11Code>
<ProductNDC>21130-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Advanced Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Better Living Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin that could cause disease. Recommended for repeaed use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42361-151-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42361-151-01) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>42361-0151-01</NDC11Code>
<ProductNDC>42361-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ac Care Bees Shield Bb</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 35</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>DongSung Pharm Co., Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>44.1; 19.6; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50594-151-19</NDCCode>
<PackageDescription>184 g in 1 BOTTLE, SPRAY (50594-151-19) </PackageDescription>
<NDC11Code>50594-0151-19</NDC11Code>
<ProductNDC>50594-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Big Lots Soundbody Spf 70 Sun Defense</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BIG LOTS STORES, INC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>300; 1500; 500; 400; 600</StrengthNumber>
<StrengthUnit>mg/10g; mg/10g; mg/10g; mg/10g; mg/10g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51346-151-01</NDCCode>
<PackageDescription>30 mL in 1 CARTON (51346-151-01)</PackageDescription>
<NDC11Code>51346-0151-01</NDC11Code>
<ProductNDC>51346-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Snail Therapy 70 Eye</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-08-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>56136-151-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (56136-151-01) </PackageDescription>
<NDC11Code>56136-0151-01</NDC11Code>
<ProductNDC>56136-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrating Mist Hand Sanitizer With Silicone Keychain Holder - Signature Scent</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Ganzhou Olivee Cosmetic Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decrease bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58503-151-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (58503-151-01) > 53 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58503-0151-01</NDC11Code>
<ProductNDC>58503-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer With Clip</ProprietaryName>
<ProprietaryNameSuffix>1.8oz</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>China Ningbo Shangge Technology Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60951-602-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60951-602-70) </PackageDescription>
<NDC11Code>60951-0602-70</NDC11Code>
<ProductNDC>60951-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Endocet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000526</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000526</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>60951-700-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60951-700-70) </PackageDescription>
<NDC11Code>60951-0700-70</NDC11Code>
<ProductNDC>60951-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Endocet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030306</StartMarketingDate>
<EndMarketingDate>20280531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030306</StartMarketingDatePackage>
<EndMarketingDatePackage>20280531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>60951-701-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (60951-701-70) </PackageDescription>
<NDC11Code>60951-0701-70</NDC11Code>
<ProductNDC>60951-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Endocet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030306</StartMarketingDate>
<EndMarketingDate>20280331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030306</StartMarketingDatePackage>
<EndMarketingDatePackage>20280331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>60951-712-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60951-712-70) </PackageDescription>
<NDC11Code>60951-0712-70</NDC11Code>
<ProductNDC>60951-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Endocet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030306</StartMarketingDate>
<EndMarketingDate>20280630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030306</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>62654-151-64</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (62654-151-64) </PackageDescription>
<NDC11Code>62654-0151-64</NDC11Code>
<ProductNDC>62654-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermacen Lotionized Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Central Solutions Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>An effective antimicrobial hand cleanser for topical application. Recommended for repeated use. Reduces transient microorganisms on intact skin. Keeps hands from drying out due to repeated uses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63481-623-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (63481-623-70) </PackageDescription>
<NDC11Code>63481-0623-70</NDC11Code>
<ProductNDC>63481-623</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Percocet</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including PERCOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>63481-627-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (63481-627-70) </PackageDescription>
<NDC11Code>63481-0627-70</NDC11Code>
<ProductNDC>63481-627</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Percocet</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990630</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990630</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use:Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS], reserve PERCOCET for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 Have not been tolerated or are not expected to be tolerated.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg*(*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.)Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg*(*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.)Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg*(*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.)Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg*(*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.)Acetaminophen, USP 325 mg. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>63481-628-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (63481-628-70) </PackageDescription>
<NDC11Code>63481-0628-70</NDC11Code>
<ProductNDC>63481-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Percocet</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20011130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including PERCOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>63481-629-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (63481-629-70) </PackageDescription>
<NDC11Code>63481-0629-70</NDC11Code>
<ProductNDC>63481-629</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Percocet</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20011130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including PERCOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>65145-151-10</NDCCode>
<PackageDescription>2 TRAY in 1 CARTON (65145-151-10) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65145-151-05) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-151-01) </PackageDescription>
<NDC11Code>65145-0151-10</NDC11Code>
<ProductNDC>65145-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219212</ApplicationNumber>
<LabelerName>Caplin Steriles Limited</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phytonadione injectable emulsion is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.Phytonadione injectable emulsion is indicated in: 1 anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;, 2 prophylaxis and therapy of hemorrhagic disease of the newborn;, 3 hypoprothrombinemia due to antibacterial therapy;, 4 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;, 5 other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione is a vitamin, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Phytonadione injectable emulsion, USP is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each milliliter contains phytonadione USP, 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 4.5 to 7.0. Phytonadione is oxygen sensitive.</Description>
</NDC>
<NDC>
<NDCCode>70108-151-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (70108-151-01) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>70108-0151-01</NDC11Code>
<ProductNDC>70108-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Vanilla Sugar Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ashtel Studios, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70108-151-02</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (70108-151-02) / 40 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>70108-0151-02</NDC11Code>
<ProductNDC>70108-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Vanilla Sugar Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ashtel Studios, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77357-151-01</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (77357-151-01) </PackageDescription>
<NDC11Code>77357-0151-01</NDC11Code>
<ProductNDC>77357-151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Desmoldantes y Aditivos, S.A. de C.V.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80638-150-12</NDCCode>
<PackageDescription>590 mL in 1 POUCH (80638-150-12) </PackageDescription>
<NDC11Code>80638-0150-12</NDC11Code>
<ProductNDC>80638-150</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Antiseptic Wet Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200918</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>FRESH CO COSMETICS SH.P.K.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decrease bacteria on skin. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80638-150-48</NDCCode>
<PackageDescription>290 mL in 1 POUCH (80638-150-48) </PackageDescription>
<NDC11Code>80638-0150-48</NDC11Code>
<ProductNDC>80638-150</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Antiseptic Wet Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200918</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>FRESH CO COSMETICS SH.P.K.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decrease bacteria on skin. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80638-600-01</NDCCode>
<PackageDescription>600 mL in 1 POUCH (80638-600-01) </PackageDescription>
<NDC11Code>80638-0600-01</NDC11Code>
<ProductNDC>80638-600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Antiseptic Wet Wipes</ProprietaryName>
<NonProprietaryName>Antibacterial Antiseptic Wet Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>FRESH CO COSMETICS SH. P.K.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DECREASES BACTERIA ON SKIN FOR USE WHEN SOAP AND WATER NOT AVAILABLE.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0054-0650-25</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0054-0650-25) </PackageDescription>
<NDC11Code>00054-0650-25</NDC11Code>
<ProductNDC>0054-0650</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215138</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 300; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg.</Description>
</NDC>
</NDCList>