Home NDC 0135-7021-03 PANADOL
Product NDC 0135-7021
Requested package NDC 0135-7021-03
11-digit product format 001357021
Labeler code 0135
Product ID 0135-7021_10c195cf-3021-2052-e063-6294a90a1ea0
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen and diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Haleon US Holdings LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-25
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 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 PANADOL
Brand name suffix 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup 1094718 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 0135-7021-01 PANADOLPM 50 in 1 CARTON TABLET, FILM COATED 50 4 0135-7021-01 PANADOLPM 2 in 1 PACKET TABLET, FILM COATED 2 4 0135-7021-02 PANADOLPM 1 in 1 CARTON TABLET, FILM COATED 1 4 0135-7021-02 PANADOLPM 24 in 1 BOTTLE TABLET, FILM COATED 24 4 0135-7021-03 PANADOLPM 50 in 1 BOTTLE TABLET, FILM COATED 50 4 0135-7021-03 PANADOLPM 1 in 1 CARTON TABLET, FILM COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-7021 PANADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 4 Current NDC, Legacy NDC, 6 package rows 20240207_fe7cd1f2-9b00-4ded-99c2-8a152c71093c.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.
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 0135-7021-03 00135702103 1 BOTTLE in 1 CARTON (0135-7021-03) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-12-07 0000-00-00 No No Current