Home NDC 57243-235 Pain Reliever PM
Product NDC 57243-235
11-digit product format 572430235
Labeler code 57243
Product ID 57243-235_ac1496d2-7b9e-468f-acdf-607a6efd98e8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Salado Sales, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1994-05-15
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 Pain Reliever 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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57243-235-15 Pain Reliever PMExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 14 57243-235-15 Pain Reliever PMExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57243-235 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240825_aef30709-f33d-48ff-b2d4-0639ffbd1ffd.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 18 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Enteric Coated ASPIRIN 81 MG Grocery Outlet 79c64e27-87aa-4081-8cbf-343768b00b90 2026-03-19 Warnings Exact identifier application number: M013 ASPIRIN LOW DOSE ASPIRIN MAJOR PHARMACEUTICALS 7c24aff7-2b96-27ac-e053-2991aa0a5714 2026-03-19 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack ea417ddb-54b3-49e2-bec1-8fe450d9990c 2026-03-19 Warnings Exact identifier application number: M013 CHILDRENS PAIN AND FEVER ACETAMINOPHEN HyVee Inc 3b08738e-cde2-4843-b609-8f12582c6d08 2026-03-18 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN AND CAFFEINE Salado Sales, Inc. 0666f082-84f3-4041-a322-311188a15670 2026-03-18 Warnings Exact identifier application number: M013 AMAZON BASICS ACETAMINOPHEN ACETAMINOPHEN Amazon.com Services LLC 3c2914a4-913e-7e50-e063-6294a90aff3a 2026-03-18 Warnings Exact identifier application number: M013 M-PAP ACETAMINOPHEN Bryant Ranch Prepack c6cec390-004e-45f6-9388-c662a979f37d 2026-03-17 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Chain Drug Marketing Association, Inc. b32ada58-a098-47d2-9ed2-4d5918657709 2026-03-16 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL H E B 21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a 2026-03-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL Topco Associates, LLC eaa98783-5800-4ae9-832f-f4a1fd1790fd 2026-03-16 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Walgreen Company 413b3b95-2867-4534-8290-54f477cccf1e 2026-03-16 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Grocery Outlet, Inc. 4454d02a-ba49-6c8c-e063-6294a90a4709 2026-03-12 Warnings Exact identifier application number: M013 Aspirin Enteric Coated ASPIRIN CVS Pharmacy c55304be-bfc0-46a8-a37e-2e6ba9098394 2026-03-12 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN Amerisource Bergen c280ac64-920c-4d03-9190-03e0196ed5ef 2026-03-11 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED d79828d8-9279-4ae9-8872-aeca641be5d9 2026-03-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Preferred Pharmaceuticals Inc. 1b5b8bb1-c45d-48f0-b275-9ce1f769fed4 2026-03-09 Warnings Exact identifier application number: M013 foster and thrive childrens pain and fever ACETAMINOPHEN Strategic Sourcing Services LLC e495a27e-eb64-4c42-8942-43bab9918172 2026-03-07 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL CVS PHARMACY 67a190c3-7de0-4f57-be94-d6b8285e1220 2026-03-06 Warnings Exact identifier application number: M013 Back and Body Pain Relief ASPIRIN, CAFFEINE WinCo Foods, LLC cf5c15e9-c45d-4bd6-a887-fd74de5f81b9 2026-03-06 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Topco Associates, LLC 87af092c-99e6-475d-81af-b9fd8fc337d7 2026-03-06 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 57243-235-15 57243023515 1 BOTTLE, PLASTIC in 1 CARTON (57243-235-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1994-05-15 0000-00-00 No No Current