Home NDC 0135-0608 PANADOL
Product NDC 0135-0608
11-digit product format 001350608
Labeler code 0135
Product ID 0135-0608_10c16df6-aa2f-03c3-e063-6294a90a93e5
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 2016-12-01
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0608-01 PANADOLPM 24 in 1 BOTTLE TABLET, FILM COATED 24 7 0135-0608-01 PANADOLPM 1 in 1 CARTON TABLET, FILM COATED 1 7 0135-0608-02 PANADOLPM 50 in 1 BOTTLE TABLET, FILM COATED 50 7 0135-0608-02 PANADOLPM 1 in 1 CARTON TABLET, FILM COATED 1 7 0135-0608-03 PANADOLPM 50 in 1 CARTON TABLET, FILM COATED 50 7 0135-0608-04 PANADOLPM 2 in 1 PACKET TABLET, FILM COATED 2 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0608 PANADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HALEON US HOLDINGS LLC] 7 Current NDC, Legacy NDC, 6 package rows 20240207_01e7dddb-755c-4745-b701-edcdb6209064.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 75 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alka-Seltzer BUFFERED ASPIRIN Lil' Drug Store Products, Inc. 0c7a60e7-0bde-9aa2-e063-6294a90a3209 2023-12-14 Warnings Exact identifier application number: M013 Circle K Aspirin 325 ASPIRIN Lil Drug Store Products, Inc 4cd306e3-2119-4272-9da4-a848fe2746fa 2023-12-14 Warnings Exact identifier application number: M013 Circle K Pain Reliever Extra Strength ACETAMINOPHEN Lil' Drug Store Products, Inc. f2359bc3-901f-4ecb-b402-cb2fe404a935 2023-12-14 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART c55b8f9d-1396-43c0-acc9-5e3485eadb07 2023-12-08 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 775519ad-5683-451f-9bfc-5fafc70c68ec 2023-12-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. c20c814b-35f5-4c46-e053-2a95a90a50f2 2023-12-08 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Better Living Brands LLC f9859be4-6d0b-2ab8-e053-6294a90aa862 2023-12-06 Warnings Exact identifier application number: M013 Aurophen Regular Strength ACETAMINOPHEN KROGER COMPANY b9b7b849-c3b3-9af7-e053-2a95a90a0077 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN KROGER COMPANY cf649478-57d2-cc88-e053-2a95a90ad1ba 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN KROGER COMPANY b9b6f878-1ec8-3dc0-e053-2995a90a5414 2023-12-06 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREEN CO. a48c522c-76c5-49f8-8c4d-3ee6b221e6f3 2023-12-06 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREEN CO. cc939a7c-ce56-5dd6-e053-2995a90aa8af 2023-12-06 Warnings Exact identifier application number: M013 Alka-Seltzer Original Flavor BUFFERED ASPIRIN, EFFERVESCENT TABLET Lil' Drug Store Products, Inc. ea5df8be-a08c-5fa3-e053-2995a90a0bac 2023-12-06 Warnings Exact identifier application number: M013 Ringl ACETAMINOPHEN Sato Pharmaceutical Co., Ltd. ba5a0286-3e0f-4bef-96e5-29d92f51f432 2023-12-06 Warnings Exact identifier application number: M013 Pain Relief Childrens ACETAMINOPHEN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 41633554-474e-4d3c-9187-d90487d2ae8c 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Family Dollar Stores, LLC f86dcbb8-debc-4bce-e053-6294a90a7a02 2023-12-05 Warnings Exact identifier application number: M013 Sanatos Multi Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBR Pharmadel LLC 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 2023-12-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 402c8563-b14b-453f-80bc-4275f1c73702 2023-12-01 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Aurohealth LLC 3ba51b52-7ae6-4335-b178-1b7b6ef36227 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC bc03fa56-8880-4bbd-81a0-91853fecdd4e 2023-11-29 Warnings Exact identifier application number: M013
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 0135-0608-01 00135060801 1 BOTTLE in 1 CARTON (0135-0608-01) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2016-12-01 0000-00-00 No No Current 0135-0608-02 00135060802 1 BOTTLE in 1 CARTON (0135-0608-02) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2016-12-01 0000-00-00 No No Current 0135-0608-03 00135060803 50 PACKET in 1 CARTON (0135-0608-03) / 2 TABLET, FILM COATED in 1 PACKET (0135-0608-04) 50 packet 2016-12-01 0000-00-00 No No Current 0135-0608-04 00135060804 2 in 1 PACKET Historical