FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
51662-1666
11-digit product format
516621666
Labeler code
51662
Product ID
51662-1666_35478de8-50d1-5d0a-e063-6294a90a88ba
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-30
Substance
ACETAMINOPHEN
Active strength
.5 g/g
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN.5 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35478de8-50d0-5d0a-e063-6294a90a88baAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1666-2ACETAMINOPHEN2 in 1 PACKETTABLET21
51662-1666-2ACETAMINOPHEN0.5 g in 1 POUCHTABLET0.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1666ACETAMINOPHEN TABLET [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Current NDC, 2 package rows20250519_35478de8-50d0-5d0a-e063-6294a90a88ba.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 31 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALGREENSb48d93fe-bb60-493f-8d1a-b2dc864203c42025-12-01WarningsExact identifier
application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWALGREEN CO.6c4ab613-a587-4ec4-9986-f1d000bc2d232025-12-01WarningsExact identifier
application number: M013
WAG HBP Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.ac2f9ce8-e402-4451-a412-e99248a6ecbe2025-12-01WarningsExact identifier
application number: M013
Walgreen Day Time NightTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESINWALGREENS CO.5505217a-9679-4668-bdab-5d4553a47c562025-12-01WarningsExact identifier
application number: M013
CAREALL AspirinASPIRINNew World Imports, Inc58a371d4-1f00-4fda-8e08-80610c58505a2025-12-01WarningsExact identifier
application number: M013
CareALL Non Aspirin Extra StrengthACETAMINOPHENNew World Imports, Incda05a1a1-35b4-4787-8c56-12e369f18ff02025-12-01WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc80a699b9-bf5c-4765-9e20-ccbc7e3ace7a2025-12-01WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc66244cdb-2680-4fa8-890d-32aefd4900382025-12-01WarningsExact identifier
application number: M013
Family Wellness Childrens Pain Reliever 574ACETAMINOPHENFamily Dollar Services, Inc.902c1136-04d2-41f0-81c6-412663cdf3782025-12-01WarningsExact identifier
application number: M013
WalgreenChildrens Pain FeverACETAMINOPHENWALGREENS CO.2f757cde-2604-4ca4-b54e-e444f3757cdd2025-11-26WarningsExact identifier
application number: M013
Walgreen Childrens Pain plus FeverACETAMINOPHENWALGREENS CO.29ca2855-3c07-435d-a8e1-2997fcedd0882025-11-26WarningsExact identifier
application number: M013
Walgreens Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.8714d4e6-3a3b-48c8-8ac1-51b933a2ceac2025-11-26WarningsExact identifier
application number: M013
Pain Reliever, 24/7 Life by 7-ElevenACETAMINOPHEN TABLET, FILM COATEDLil' Drug Store Products, Inc.44828b89-2563-b233-e063-6294a90ab1242025-11-26WarningsExact identifier
application number: M013
MEMBERS MARK ACETAMINOPHENACETAMINOPHENSam's West Inc03e831d4-8060-4633-9d02-e77100063fb42025-11-26WarningsExact identifier
application number: M013
Childrens Pain and Fever Dissolve PacksACETAMINOPHENWALGREENS CO.ea0f265f-7d64-4731-beda-0bb841dd1ad72025-11-25WarningsExact identifier
application number: M013
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLATLANTIC BIOLOGICALS CORP.71a80e13-bda3-40fb-b4e7-45e9985e707c2025-11-24WarningsExact identifier
application number: M013
Low Dose AspiriunASPIRINAMERIFOODS TRADING COMPANY3802c96a-5e2a-ba9c-e063-6394a90abb782025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227aeb1-dd2c-9ca1-e063-6294a90ad7092025-11-20WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharamceuticals, Inc.440c13d7-edf0-f611-e063-6394a90af9952025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227a2cc-69fa-869d-e063-6294a90a1d412025-11-20WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN35478de8-50d0-5d0a-e063-6294a90a88ba1
198440acetaminophen 500 MG Oral TabletSCD35478de8-50d0-5d0a-e063-6294a90a88ba1
198440APAP 500 MG Oral TabletSY35478de8-50d0-5d0a-e063-6294a90a88ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1666-2516621666022 POUCH in 1 PACKET (51662-1666-2) / .5 g in 1 POUCH2 pouch2020-01-30NoNoCurrent