Home NDC 81522-095 Acetaminophen PM
Product NDC 81522-095
11-digit product format 815220095
Labeler code 81522
Product ID 81522-095_2499e0c3-bbc3-58aa-e063-6294a90a4ed5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler FSA STORE INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-02
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen PM
Listing expiration 2026-12-31 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 81522-095-03 Acetaminophen PM 1 in 1 CARTON TABLET, COATED 1 3 81522-095-03 Acetaminophen PM 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-095 ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FSA STORE INC.] 3 Current NDC, 2 package rows 20241018_f4322f34-ac19-371e-e053-2a95a90ac864.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 1 of 85 · 1,689 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY e4cbfb06-d826-4d08-95d6-60305c417625 2026-08-14 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN CVS Pharmacy,Inc. 3738d35c-1e83-40df-9292-c54e6b2c8353 2026-08-14 Warnings Exact identifier application number: M013 CVS Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY 22a48a33-995b-481e-9e4e-1ad7ec346f44 2026-08-14 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Topco Associates, LLC 8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101 2026-08-12 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN HARRIS TEETER 54e69d5a-55d7-4ebe-8494-0be93613f1e2 2026-08-12 Warnings Exact identifier application number: M013 Chewable Aspirin ASPIRIN HARRIS TEETER c6a28c83-60c9-3304-e053-2a95a90aa06c 2026-08-12 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN HARRIS TEETER 93cbd3cb-1072-89e6-e053-2995a90a2f15 2026-08-12 Warnings Exact identifier application number: M013 Adult Chewable Aspirin ASPIRIN HARRIS TEETER c6a28617-1769-7a7d-e053-2995a90a1ea0 2026-08-12 Warnings Exact identifier application number: M013 Gencare- Pain Relief Acetaminophen ACETAMINOPHEN Pioneer Life Sciences, LLC 2111c91b-2fd7-4ab3-946a-d4e0cf46399a 2026-08-12 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN Salado Sales, Inc. 1dbd8480-5cb4-4577-9091-b2a2add4f1af 2026-08-12 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation 29ecdd2d-aeaf-40a8-a347-011088009ea6 2026-08-11 Warnings Exact identifier application number: M013 Fast Acting Pedia Crae ACETAMINOPHEN Randob Labs., Ltd. e069060f-fbb2-4c7a-b872-00b3ab86d01b 2026-08-11 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN Amazon.com Services LLC c7cc0681-4c0b-4565-99df-d0168c8ba1ba 2026-08-10 Warnings Exact identifier application number: M013 GenCare Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Pioneer Life Sciences, LLC ac8c4bdf-30c9-2b09-e053-2a95a90a9b67 2026-08-09 Warnings Exact identifier application number: M013 Gencare-Aspirin Low Dose Pain reliever (NSAID) ASPIRIN Pioneer Life Sciences, LLC 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc 2026-08-09 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN DOLGENCORP, LLC b4064039-2345-4227-b83d-54dc13a838d3 2026-08-07 Warnings Exact identifier application number: M013 berkley and jensen acetaminophen ACETAMINOPHEN BJWC dee57d73-73ac-48bb-b1da-9971f1ff21c4 2026-08-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN P & L Development, LLC 4cd74cec-a209-4e92-b853-fbe5c95f7678 2026-08-06 Warnings Exact identifier application number: M013 Tension Headache Aspirin-Free ACETAMINOPHEN, CAFFEINE Rite Aid Corporation 093a7c26-f2b1-4416-b193-81133d247d2e 2026-08-06 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bc17b2e5-4828-6a2e-e053-2995a90a8c63 2026-08-05 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 Sample Exclude flag Status 81522-095-03 81522009503 1 BOTTLE, PLASTIC in 1 CARTON (81522-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-05-02 No No Current