Home NDC 53345-010 ACETAMINOPHEN (RED)
Product NDC 53345-010
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 6 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join childrens fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation a63727c3-64d8-4ae9-8da3-974cae6beed2 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC e4a2566e-48ec-4602-87e3-143398d15f33 2026-07-24 Warnings Exact identifier application number: M013 infants fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation 920e7055-7ed1-4db4-9215-f8933078bb7b 2026-07-24 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens c6665c11-9a01-4472-a444-acadb1de0b69 2026-07-23 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 103d109d-f520-409c-8da2-eb6b0fbec891 2026-07-22 Warnings Exact identifier application number: M013 Tylenol PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC ce58105b-f010-47af-8f31-6dd4ce4e9cba 2026-07-22 Warnings Exact identifier application number: M013 GOOD SENSE INFANTS PAIN AND FEVER ACETAMINOPHEN L. Perrigo Company a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7 2026-07-22 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Cardinal Health 107, LLC 7562f4e4-54fa-488c-a199-48ad2632e2a1 2026-07-21 Warnings Exact identifier application number: M013 Medline ACETAMINOPHEN Medline Industries, LP 4b1d7243-b943-4e2b-e063-6294a90a2c4e 2026-07-20 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN LEADER/ Cardinal Health 110, Inc. 7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d 2026-07-16 Warnings Exact identifier application number: M013 Rapidol 500 Extra Strength ACETAMINOPHEN Pharmadel LLC 1d9fa7ec-a509-28b2-e063-6294a90a7831 2026-07-16 Warnings Exact identifier application number: M013 equate pain relief ACETAMINOPHEN WALMART INC. 2f9b2550-5476-49ae-b741-54416a40bc29 2026-07-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL HyVee Inc 4f45a750-1220-4a81-801e-bf08c9d117d6 2026-07-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Dr. Reddy's Laboratories Inc. 9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f 2026-07-15 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Family Dollar, Inc. 3f182571-3212-eb29-e063-6294a90a9fa0 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN DOLGENCORP, LLC 955484a6-2a7a-4b15-a9b4-e888ed5de04c 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Geri-Care Pharmaceuticals, Corp 58941782-362d-4436-b365-e909bdbd29a2 2026-07-15 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Major Pharmaceuticals 44730dfb-5062-4015-924b-c30b6c2b19c2 2026-07-13 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Cardinal Health 110, LLC. DBA Leader f1cd0d59-12a8-4ff2-942a-6faa6907ef05 2026-07-13 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen 2c5e80e8-a979-45fb-9297-8ff294280c25 2026-07-13 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 53345-010-02 53345001002 1 BAG in 1 BOX (53345-010-02) / 4000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2016-04-04 0000-00-00 No No Current