Home NDC 54473-304 CounterAct
Product NDC 54473-304
11-digit product format 544730304
Labeler code 54473
Product ID 54473-304_7fbf2b51-9097-0a1f-e053-2991aa0a6aa1
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine
Dosage form TABLET
Route ORAL
Labeler Melaleuca, Inc.
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2016-05-02
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 CounterAct
Brand name suffix PM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 500 mg/1 ACETAMINOPHEN 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup 362O9ITL9D 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 54473-304-01 CounterActPM 1 in 1 BOX TABLET 1 2 54473-304-50 CounterActPM 50 in 1 BOTTLE TABLET 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-304 COUNTERACT PM (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET [MELALEUCA, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20190119_7f9a0062-0e86-1deb-e053-2a91aa0a9188.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54473-304-01 54473030401 1 BOTTLE in 1 BOX (54473-304-01) / 50 TABLET in 1 BOTTLE (54473-304-50) 1 bottle 2016-05-02 0000-00-00 No No Current 54473-304-50 54473030450 50 in 1 BOTTLE Historical