Home NDC 63029-053 Percogesic
Product NDC 63029-053
11-digit product format 630290053
Labeler code 63029
Product ID 63029-053_6a927a49-32fc-4139-b0fe-7d2520495273
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Medtech Products Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-03-19
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 325; 12.5 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Percogesic
Brand name suffix Original Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 12.5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1052462 Internal RxNorm lookup 1052466 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 63029-053-24 PercogesicOriginal Strength 1 in 1 BOX TABLET, COATED 1 2 63029-053-24 PercogesicOriginal Strength 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 2 63029-053-50 PercogesicOriginal Strength 1 in 1 BOX TABLET, COATED 1 2 63029-053-50 PercogesicOriginal Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 2 63029-053-90 PercogesicOriginal Strength 1 in 1 BOX TABLET, COATED 1 2 63029-053-90 PercogesicOriginal Strength 90 in 1 BOTTLE, PLASTIC TABLET, COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63029-053 PERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 Current NDC, 6 package rows 20250116_529974c2-0121-4892-8e47-c2c447581091.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 67 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join topcare infants pain and fever ACETAMINOPHEN Topco Associates LLC f1e940ef-3cf0-4a5c-8158-156d0e5a680d 2024-06-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Trifecta Pharmaceuticals USA LLC 026bf664-d598-73de-e063-6394a90a9206 2024-06-12 Warnings Exact identifier application number: M013 Regular Strength Pain Relief ACETAMINOPHEN NuCare Pharmaceuticals,Inc. 7c73fc75-af9b-177c-e053-2a91aa0ada56 2024-06-12 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Topco Associates 4a6a1dbb-c813-42fd-9bb8-497aec339466 2024-06-11 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE The Kroger Co. fa234639-caf8-4c52-9ffe-f1c0c057ee5b 2024-06-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE The Kroger Co. bc18590d-6481-4efe-8a3b-974f7543b754 2024-06-10 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN H-E-B 085b35db-62e4-38db-e063-6394a90a9763 2024-06-07 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Meijer Distribution Inc cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf 2024-06-07 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE The Kroger Co. 5691ac45-5732-412e-abb8-2bfaac59160e 2024-06-07 Warnings Exact identifier application number: M013 Cafiaspirina Rapid Headache Relief ASPIRIN, CAFFEINE Belmora LLC d890acec-6528-4fb7-8d59-6c572a3f0786 2024-06-07 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE TARGET Corporation 611bc1ce-460a-44a3-8e2d-b28a399d9a44 2024-06-06 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 033a6153-2651-4703-8a94-def461838113 2024-06-05 Warnings Exact identifier application number: M013 CareOne Childrens Acetaminophen ACETAMINOPHEN American Sales Company 126ee71a-c408-415b-9a43-502337a91055 2024-06-05 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN A-S Medication Solutions 85294a70-3233-4ba5-bc36-ee3f2964aebf 2024-06-05 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN 81MG Lodaat LLC 6a35f38c-a240-4f8c-9a8e-8d283b67b55b 2024-06-04 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN 81MG Lodaat LLC 1ec12f4b-de05-4990-a7b7-f82d867361de 2024-06-04 Warnings Exact identifier application number: M013 CareOne Infants Acetaminophen ACETAMINOPHEN American Sales Company 0a28a4f1-d947-489b-be28-36ba10b581cf 2024-06-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack 77fb237f-28b5-486b-b9ef-cb324d5cc0bd 2024-05-30 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack b5053cf5-209d-4106-afc2-cf9af85f4a69 2024-05-29 Warnings Exact identifier application number: M013 topcare infants pain and fever ACETAMINOPHEN Topco Associates LLC f129bc0e-1ef1-42a8-8668-2ee88ffc85e3 2024-05-23 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 63029-053-24 63029005324 1 in 1 BOX Historical 63029-053-50 63029005350 1 in 1 BOX Historical 63029-053-90 63029005390 1 BOTTLE, PLASTIC in 1 BOX (63029-053-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC 2010-03-19 No No Current