Home NDC 53345-010-01 ACETAMINOPHEN (RED)
Product NDC 53345-010
Requested package NDC 53345-010-01
11-digit product format 533450010
Labeler code 53345
Product ID 53345-010_27c732b5-1662-f46a-e063-6394a90a9eb4
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-04-15
Substance ACETAMINOPHEN
Active strength 325 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 ACETAMINOPHEN (RED)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 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 198436 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 53345-010-01 ACETAMINOPHEN (RED) 5000 in 1 BAG CAPSULE, LIQUID FILLED 5000 3 53345-010-01 ACETAMINOPHEN (RED) 1 in 1 BOX CAPSULE, LIQUID FILLED 1 3 53345-010-02 ACETAMINOPHEN (RED) 4000 in 1 BAG CAPSULE, LIQUID FILLED 4000 3 53345-010-02 ACETAMINOPHEN (RED) 1 in 1 BOX CAPSULE, LIQUID FILLED 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-010 ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] 3 Current NDC, Legacy NDC, 2 package rows 20241127_a352f588-4a70-42b2-8f9c-a73a0629517d.zip 53345-010 ACETAMINOPHEN (RED) (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 3 Current NDC, Legacy NDC, 2 package rows 20241127_06eabf4b-f8c0-439a-acf1-aa6e3075c717.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 68 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Good Neighbor Pharmacy Childrens Pain and Fever ACETAMINOPHEN Amerisource Bergen 074fdf65-f6ce-46d4-87cc-46911c01cca5 2024-05-23 Warnings Exact identifier application number: M013 DG Health Childrens Pain and Fever ACETAMINOPHEN Dolgencorp, LLC 779cf607-245f-408a-81e8-8000c0ea4c4a 2024-05-22 Warnings Exact identifier application number: M013 good sense pain and fever infants ACETAMINOPHEN L. Perrigo Company 7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb4 2024-05-21 Warnings Exact identifier application number: M013 Extra Strength Night Time Pain Medicine ACETAMINOPHEN, DIPHENHYDRAMINE HCL Geri-Care Pharmaceutical Corp 2b8f83ed-1ca9-49ac-9b2a-2609b68200f9 2024-05-21 Warnings Exact identifier application number: M013 Acetaminophen Solution ACETAMINOPHEN Patrin Pharma, Inc. 52ae729b-2255-420c-8db8-cabdc2b74796 2024-05-21 Warnings Exact identifier application number: M013 Ibuprofen, Lil Drug Store IBUPROFEN Lil' Drug Store products, Inc. 18e80dab-6837-fd2d-e063-6294a90a73c8 2024-05-20 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN QUALITY CHOICE (Chain Drug Marketing Association) 2f9da3d6-229d-44d1-bd94-4bcddbbdb120 2024-05-20 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 07d34e7a-c0c6-f3c4-e063-6294a90aa5c3 2024-05-18 Warnings Exact identifier application number: M013 AMAZON BASIC CARE ACETAMINOPHEN ACETAMINOPHEN Amazon.com Services LLC 10ee2f40-858d-bed4-e063-6394a90a86bb 2024-05-17 Warnings Exact identifier application number: M013 TYLENOL EXTRA STRENGTH ACETAMINOPHEN A-S Medication Solutions bcb7eb24-16cb-439e-879f-48d2f5e8ba83 2024-05-17 Warnings Exact identifier application number: M013 Basic Care Childrens Pain and Fever ACETAMINOPHEN Amazon.com Services LLC 26266777-185d-4110-a8a7-56846aab2542 2024-05-17 Warnings Exact identifier application number: M013 TYLENOL EXTRA STRENGTH ACETAMINOPHEN A-S Medication Solutions 1b4db77f-b254-4db5-8e98-d46850140a9b 2024-05-16 Warnings Exact identifier application number: M013 KOSHER MEDS Childrens Pain and Fever ACETAMINOPHEN Mollec Inc 4d01c9ee-26be-4cdd-b52d-7fa344c1933a 2024-05-15 Warnings Exact identifier application number: M013 Kosher Meds Childrens Allergy Relief DIPHENHYDRAMINE HCL Mollec Inc 42ad618b-d2e5-4c58-9407-386df4fe4004 2024-05-15 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN P & L Development, LLC 1c081a7c-8cff-4253-97ac-5fa74a5c0668 2024-05-10 Warnings Exact identifier application number: M013 dg health childrens pain and fever ACETAMINOPHEN Dolgencorp Inc 1d794621-9836-4ab8-92ee-fcd916964567 2024-05-09 Warnings Exact identifier application number: M013 Aspirin 81mg Dye-Free ASPIRIN 81MG Allegiant Health 26ad090d-7193-45c2-82eb-a2bc81955fe6 2024-05-08 Warnings Exact identifier application number: M013 basic care infants pain and fever ACETAMINOPHEN Amazon.com Services LLC 40329d8c-eb3d-4143-b4ae-9bafd0a1cb3c 2024-05-08 Warnings Exact identifier application number: M013 childrens pain and fever ACETAMINOPHEN Walgreen Company 928bb80e-2e14-488c-99ab-abb860cbe7a8 2024-05-07 Warnings Exact identifier application number: M013 basic care childrens pain and fever ACETAMINOPHEN Amazon.com Services LLC 790d8883-52be-46f2-9838-564b6c5d57f9 2024-05-07 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 53345-010-01 53345001001 1 BAG in 1 BOX (53345-010-01) / 5000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2013-04-15 0000-00-00 No No Current