Home NDC 68196-556 acetaminophen pm
Product NDC 68196-556
11-digit product format 681960556
Labeler code 68196
Product ID 68196-556_2b701514-75fd-46d0-95c2-0adc9e9a383f
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Sam's West Inc
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-12-17
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base acetaminophen pm
Brand name suffix extra strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68196-556-54 acetaminophen pmextra strength 375 in 1 BOTTLE, PLASTIC TABLET, COATED 375 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SAM'S WEST INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68196-556 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [SAM'S WEST INC] 13 Current NDC, Legacy NDC, 1 package rows 20240829_cff9a730-2241-4e4c-bf6b-a2fa895e2417.zip
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 59 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68196-556-54 68196055654 375 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-556-54) 2007-12-17 0000-00-00 No No Current