Home NDC 53345-019 Pain Relief Extra Strength
Product NDC 53345-019
11-digit product format 533450019
Labeler code 53345
Product ID 53345-019_27c7638c-508b-3868-e063-6394a90af73b
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 2014-01-06
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Pain Relief 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 198439 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 53345-019-01 Pain Relief Extra Strength 1 in 1 BOX CAPSULE, LIQUID FILLED 1 5 53345-019-01 Pain Relief Extra Strength 3000 in 1 BAG CAPSULE, LIQUID FILLED 3000 5 53345-019-02 Pain Relief Extra Strength 1 in 1 BOX CAPSULE, LIQUID FILLED 1 5 53345-019-02 Pain Relief Extra Strength 2000 in 1 BAG CAPSULE, LIQUID FILLED 2000 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-019 PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 5 Current NDC, Legacy NDC, 4 package rows 20241127_5c42dd28-820c-4cc5-9016-11ad5e580616.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 · 1,692 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN Walgreens 543f93d1-df14-0bd2-e063-6294a90a4413 2026-08-24 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Akron Pharma Inc. ab79fd60-8315-4c63-8045-1b0511ac268f 2026-08-24 Warnings Exact identifier application number: M013 Genexa Infants Pain and Fever ACETAMINOPHEN Genexa Inc. 4fd048c3-70bc-2ea7-e063-6394a90a55f2 2026-08-22 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 59adabeb-97e8-2de4-e063-6394a90acc47 2026-08-22 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Publix Super Markets Inc a876daa7-ade3-497d-87bb-46d6e4dc185a 2026-08-21 Warnings Exact identifier application number: M013 equate aspirin ASPIRIN Wal-Mart Stores Inc ea3f8eed-7b70-4156-9586-125d27bf29a8 2026-08-19 Warnings Exact identifier application number: M013 CARDIASPIRIN PROTECT ASPIRIN OPMX LLC 03774690-662b-1c30-e063-6294a90a3488 2026-08-19 Warnings Exact identifier application number: M013 aspirin chewable, low dose ASPIRIN United Natural Foods, Inc. dba UNFI 6a6ac7fe-91a4-4b55-979a-b53b51505d8b 2026-08-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Sam's West Inc 1098d0e7-8202-4018-a2d2-b0c80ee58b56 2026-08-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Safeway, Inc. 5e77dca4-2ff8-4a8c-94bd-f224b680ca23 2026-08-19 Warnings Exact identifier application number: M013 dg health pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Dolgencorp Inc 4d1eddf0-eff7-4c47-b312-30dee08d9e5f 2026-08-19 Warnings Exact identifier application number: M013 Headache Formula Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE ARMY AND AIR FORCE EXCHANGE SERVICE ee8d0961-7572-471f-8c96-b4c0bd354de2 2026-08-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Rugby Laboratories 76f10ee2-1d6a-097c-e053-2991aa0af526 2026-08-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Major Pharmaceuticals 780aad35-d0f1-44b1-e053-2991aa0af9a7 2026-08-18 Warnings Exact identifier application number: M013 CHILDRENS PAIN AND FEVER ACETAMINOPHEN Amazon.com Services LLC 5eacbc4f-d20a-4c22-9680-4a648e24de43 2026-08-18 Warnings Exact identifier application number: M013 Pain Relief Childrens ACETAMINOPHEN WinCo Foods, LLC 15921c3f-e8d4-4794-983f-63bb926f6f86 2026-08-15 Warnings Exact identifier application number: M013 Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY e4cbfb06-d826-4d08-95d6-60305c417625 2026-08-14 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN CVS Pharmacy,Inc. 3738d35c-1e83-40df-9292-c54e6b2c8353 2026-08-14 Warnings Exact identifier application number: M013 CVS Childrens Pain plus Fever Relief ACETAMINOPHEN CVS PHARMACY 22a48a33-995b-481e-9e4e-1ad7ec346f44 2026-08-14 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN AND CAFFEINE CVS Pharmacy 31ccc867-ca83-70a9-f3d5-5644030047b8 2026-08-13 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 53345-019-01 53345001901 1 BAG in 1 BOX (53345-019-01) / 3000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2014-01-06 0000-00-00 No No Current 53345-019-02 53345001902 1 BAG in 1 BOX (53345-019-02) / 2000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2014-01-06 0000-00-00 No No Current