Home NDC 63029-054 Percogesic
Product NDC 63029-054
11-digit product format 630290054
Labeler code 63029
Product ID 63029-054_dd068345-eb74-40b1-80b5-ef9df6fde1cd
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen and diphenhydramine
Dosage form CAPSULE, COATED
Route ORAL
Labeler Medtech Products Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-07-07
Substance ACETAMINOPHEN; DIPHENHYDRAMINE
Active strength 500; 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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Percogesic
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE 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 8GTS82S83M Internal UNII 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 63029-054-40 PercogesicExtra Strength 1 in 1 CARTON CAPSULE, COATED 1 1 63029-054-40 PercogesicExtra Strength 40 in 1 BOTTLE, PLASTIC CAPSULE, COATED 40 1 63029-054-60 PercogesicExtra Strength 1 in 1 CARTON CAPSULE, COATED 1 1 63029-054-60 PercogesicExtra Strength 60 in 1 BOTTLE, PLASTIC CAPSULE, COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63029-054 PERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.] 1 Current NDC, 4 package rows 20240308_2c5f1140-fb83-42c9-b0b1-5e2bd69340bb.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 · 1,681 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 63029-054-40 63029005440 1 BOTTLE, PLASTIC in 1 CARTON (63029-054-40) / 40 CAPSULE, COATED in 1 BOTTLE, PLASTIC 2010-07-07 No No Current 63029-054-60 63029005460 1 BOTTLE, PLASTIC in 1 CARTON (63029-054-60) / 60 CAPSULE, COATED in 1 BOTTLE, PLASTIC 2010-07-07 No No Current