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 5 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SurviveX Travel Med MOD CONVENIENCE KIT Intent Brands LLC 522da86b-cfd7-dd20-e063-6394a90a51c6 2026-08-04 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever mini softgels ACETAMINOPHEN 500 MG Shield Pharmaceuticals Corp 0ebb1902-6f8a-4bfb-9f2e-839d43bfca37 2026-08-04 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Better Living Brands, LLC 743af02c-c762-42f5-8e01-2f62da15e04e 2026-08-04 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC 9aea8aae-8702-4c93-8b07-69cd252f44d6 2026-08-03 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen 325 mg ACETAMINOPHEN NUVICARE LLC 49a59b79-b8b4-4bf5-a403-0a14751efc55 2026-08-03 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC d4e98f8e-f24c-4bdd-b750-fa4f877fb621 2026-07-31 Warnings Exact identifier application number: M013 KinderFarms Childrens Pain and Fever ACETAMINOPHEN KinderFarms, LLC 4f86419a-b940-a9c6-e063-6394a90a6a2b 2026-07-30 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Family Dollar Stores, LLC 53f7a9c8-f40e-19b2-e063-6394a90a8695 2026-07-29 Warnings Exact identifier application number: M013 KinderFarms Infants Pain and Fever ACETAMINOPHEN KinderFarms, LLC 5468b149-8fac-8d6a-e063-6294a90a8c51 2026-07-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS PHARMACY 258975d2-d8e8-407d-9804-df3b37a184e4 2026-07-29 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3ba0a9f2-062a-401e-82eb-54383a822366 2026-07-29 Warnings Exact identifier application number: M013 Aspirin 81mg Enteric Coated ASPIRIN Cardinal Health 107, LLC 277723db-3578-4842-92eb-2de325f87649 2026-07-28 Warnings Exact identifier application number: M013 Aspirin Low Dose Chewable ASPIRIN Better Living Brands, LLC 7afce7b4-c86a-43f7-83cf-15ebffba2f35 2026-07-28 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC f818996c-36d2-4d3d-af3e-39949157edb9 2026-07-28 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L.N.K. International, Inc. 03b871e8-3e14-4ed8-a978-45129255b272 2026-07-27 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HCL Rite Aid Corporation 17d27771-a112-474f-9a58-29af0d7e1af3 2026-07-27 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC 2143cc16-86db-4060-96da-5c228ae9207b 2026-07-24 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Softgel Healthcare Pvt Ltd 352bb451-ffdc-411a-e063-6294a90a8cf5 2026-07-24 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN NuCare Pharmaceuticals,Inc. fdb7331a-d029-8b2a-e053-6294a90adfcd 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC 5ada044e-50e8-4874-ac04-df5f1f9e735d 2026-07-24 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