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 9 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Low Dose ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN CVS PHARMACY 5e35df92-6282-4ca6-902b-bb6bd326b487 2026-06-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Orelli Inc. 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d 2026-06-22 Warnings Exact identifier application number: M013 Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Exact identifier application number: M013 Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DOLGENCORP, LLC acc94a3e-21b6-4375-9881-38cf9bab8692 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE DOLGENCORP, LLC e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 2026-06-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Oncor Pharmaceuticals 4c396d0e-aa93-4f9e-b065-2e606f7f05cd 2026-06-17 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN Famora Inc. 4dc6f119-bbde-db5f-e063-6294a90a9486 2026-06-16 Warnings Exact identifier application number: M013 Childrens Pain and Fever Relief ACETAMINOPHEN Chain Drug Marketing Association, Inc. 420a1e05-caa6-481f-bdab-a670f0220f96 2026-06-16 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DOLGENCORP, LLC ce9f4e0d-43fb-499a-b8a2-a997a14841c4 2026-06-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN L.N.K. International, Inc. 734cc3d2-6fc5-4dcc-93ed-0b57c1f01345 2026-06-15 Warnings Exact identifier application number: M013 RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d63671d-cf7c-bbdd-e063-6294a90affef 2026-06-15 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 59773893-09a8-47a2-943a-e9ea9da4458a 2026-06-15 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Shield Pharmaceuticals Corp. 96eb7f9f-ff2d-4661-bbe6-1860aafe03f6 2026-06-15 Warnings Exact identifier application number: M013 Duralgina Extra Strength ACETAMINOPHEN Menper Distributors, Inc. 544e3d7e-a759-384f-e063-6294a90a5baa 2026-06-15 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation be2286a1-946b-4bf5-b14c-8e86da669594 2026-06-15 Warnings Exact identifier application number: M013 Aspirin 81 ASPIRIN Amerisource Bergen 4491faca-f30b-4eb0-bea9-f518f6b2f095 2026-06-15 Warnings Exact identifier application number: M013
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