FDA.reportPublic FDA data

Acetaminophen

Product NDC
57237-346
Requested package NDC
57237-346-10
11-digit product format
572370346
Labeler code
57237
Product ID
57237-346_d19afb8f-7095-47fb-ae86-6efa69764655
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-09
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
57237-346-01Acetaminophen100 in 1 BOTTLETABLET, FILM COATED1004
57237-346-10Acetaminophen1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-346-01EA - Each57237-3462ccb0212-ce31-48f1-bb7c-e48bd05936bd12025-08-11
57237-346-10EA - Each57237-34639d36403-64f2-4dbf-ad05-c27fd026367a12025-11-13

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 79 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWestminster Pharmaceuticals, LLCace5ebac-ec11-4c26-b1e3-954b450ee6712021-05-04WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health8cacf02c-9925-40d4-92bc-78788aa0681a2020-11-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
application number: M013
Acetaminophen 500mg ESACETAMINOPHEN 500MGAllegiant Health91acc132-01b6-467b-9af5-70f4dc93e0872019-01-08WarningsExact identifier
application number: M013
Acetaminophen 325mg RSACETAMINOPHEN 325MGAllegiant Health61c6d281-e59b-4277-bbce-f71c12c2a56d2019-01-07WarningsExact identifier
application number: M013
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAllegiant Health9a4c0c43-a71a-4e22-a3d5-9eb9622689a22019-01-02WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
application number: M013
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
application number: M013
Aspirin ChewableASPIRIN 81 MGAllegiant Health92b8637b-03a9-461f-b2f6-6eddaa2149532018-12-21WarningsExact identifier
application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
application number: M013
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
application number: M013
ASPIRIN Enteric CoatedASPIRIN 81 MGAllegiant Health5910a882-eb40-440f-8a30-c21fbce9050e2018-11-07WarningsExact identifier
application number: M013
AspirinASPIRIN 325 MGAllegiant Health88b54062-8b3d-4024-a957-62b3255184b92018-11-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe52018-11-07WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
application number: M013
SED-MAXACETAMINOPHEN 500 MG WITH CAFFEINE 65MGCommand Brands, LLC4920a0e9-6f88-4df0-8657-77c95a3b96172017-01-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNbd5e6804-4df4-4a65-92e4-faa3a0f7c0054
313782acetaminophen 325 MG Oral TabletSCDbd5e6804-4df4-4a65-92e4-faa3a0f7c0054
313782APAP 325 MG Oral TabletSYbd5e6804-4df4-4a65-92e4-faa3a0f7c0054
313782acetaminophen 325 MG Oral TabletPSN19735691-33f3-4e19-85ad-e5f270251ec51
313782acetaminophen 325 MG Oral TabletPSN1f4ac0e6-e986-4c22-8248-0691d64e1a301
313782acetaminophen 325 MG Oral TabletPSN816b65d7-e53f-44c4-a418-074279d4b2af1
313782acetaminophen 325 MG Oral TabletSCD19735691-33f3-4e19-85ad-e5f270251ec51
313782acetaminophen 325 MG Oral TabletSCD1f4ac0e6-e986-4c22-8248-0691d64e1a301
313782acetaminophen 325 MG Oral TabletSCD816b65d7-e53f-44c4-a418-074279d4b2af1
313782APAP 325 MG Oral TabletSY19735691-33f3-4e19-85ad-e5f270251ec51
313782APAP 325 MG Oral TabletSY1f4ac0e6-e986-4c22-8248-0691d64e1a301
313782APAP 325 MG Oral TabletSY816b65d7-e53f-44c4-a418-074279d4b2af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
57237-346-10572370346101000 TABLET, FILM COATED in 1 BOTTLE (57237-346-10) 2025-07-09NoNoCurrent