Home NDC 83324-078 Pain Relief
Product NDC 83324-078
11-digit product format 833240078
Labeler code 83324
Product ID 83324-078_458b4f7d-8f0c-2559-e063-6294a90a663b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION, INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-03
Substance ACETAMINOPHEN
Active strength 500 mg/1
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 Pain Relief
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-078-01 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-01 Pain ReliefExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3 83324-078-05 Pain ReliefExtra Strength 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 3 83324-078-15 Pain ReliefExtra Strength 150 in 1 BOTTLE, PLASTIC TABLET, COATED 150 3 83324-078-24 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-24 Pain ReliefExtra Strength 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 3 83324-078-50 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-50 Pain ReliefExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-078 PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.] 2 Current NDC, 8 package rows 20240615_c57c10fc-f182-4153-8974-ef359a5f5ac1.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 Marketing start Sample Exclude flag Status 83324-078-01 83324007801 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current 83324-078-05 83324007805 500 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-05) 2024-04-03 No No Current 83324-078-15 83324007815 150 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-15) 2024-04-03 No No Current 83324-078-24 83324007824 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current 83324-078-50 83324007850 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current