FDA.reportPublic FDA data

NDC 00591-0385 - HYDROCODONE BITARTRATE AND ACETAMINOPHEN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
00591-0385
Manufacturer
Keltman Pharmaceuticals Inc.
Effective date
2010-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
hydrocodone bitartrate and acetaminophen tabletKeltman Pharmaceuticals Inc.2010-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [KELTMAN PHARMACEUTICALS INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 130 of 155 · 3,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2f9da3d6-229d-44d1-bd94-4bcddbbdb1202024-05-20WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEStrides Pharma Science Limitedc459ed02-afd6-4533-82b6-bfb2c7ab0e722024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS07d34e7a-c0c6-f3c4-e063-6294a90aa5c32024-05-18WarningsExact identifier
unii: 362O9ITL9D
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC10ee2f40-858d-bed4-e063-6394a90a86bb2024-05-17WarningsExact identifier
unii: 362O9ITL9D
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutionsbcb7eb24-16cb-439e-879f-48d2f5e8ba832024-05-17WarningsExact identifier
unii: 362O9ITL9D
Basic Care Childrens Pain and FeverACETAMINOPHENAmazon.com Services LLC26266777-185d-4110-a8a7-56846aab25422024-05-17WarningsExact identifier
unii: 362O9ITL9D
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutions1b4db77f-b254-4db5-8e98-d46850140a9b2024-05-16WarningsExact identifier
unii: 362O9ITL9D
TenconBUTALBITAL AND ACETAMINOPHENEl Dorado Distributors LLC4e4a9925-67aa-4be7-8bb7-c8b058ffe2232024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
KOSHER MEDS Childrens Pain and FeverACETAMINOPHENMollec Inc4d01c9ee-26be-4cdd-b52d-7fa344c1933a2024-05-15WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.d6ac0d70-0511-4ec8-bb35-8b2e0e3d77422024-05-15WarningsExact identifier
unii: 362O9ITL9D
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113df1bc-a217-33ea-e063-6294a90a46432024-05-14WarningsExact identifier
unii: 362O9ITL9D
Cold Flu and Sore Throat Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway, Inc.6c952c81-c8b6-4e74-abd8-781f6f44736b2024-05-14WarningsExact identifier
unii: 362O9ITL9D
Pain and Sinus RelieverACETAMINOPHEN AND PHENYLEPHRINEJHK DBA American Safety & First Aid249373c6-f56f-4bd3-9cef-98b7ee73457d2024-05-14WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.a70ead03-6d2c-44c1-9ae5-f6c4094821ec2024-05-14WarningsExact identifier
unii: 362O9ITL9D
Day Time Cold and Flu Relief non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.cc450f89-a156-48e0-82ae-19782f13c2ca2024-05-13WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.ef0cd436-5e81-47a7-92d6-58495283ab282024-05-13WarningsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENP & L Development, LLC1c081a7c-8cff-4253-97ac-5fa74a5c06682024-05-10WarningsExact identifier
unii: 362O9ITL9D
dg health childrens pain and feverACETAMINOPHENDolgencorp Inc1d794621-9836-4ab8-92ee-fcd9169645672024-05-09WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANY10106c90-f2f0-508e-e063-6294a90a544b2024-05-08WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATEKroger1013ce02-7b12-335e-e063-6394a90af3e62024-05-08WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.