FDA.reportPublic FDA data

Acetaminophen

Product NDC
69367-323
Requested package NDC
69367-323-04
11-digit product format
693670323
Labeler code
69367
Product ID
69367-323_f382f280-b5cf-4f4b-869b-285ed012c19e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-05
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
ACETAMINOPHEN160 mg/5mL

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
307675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ace5ebac-ec11-4c26-b1e3-954b450ee671Available 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product 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
69367-323-04Acetaminophen118 mL in 1 BOTTLE, PLASTICLIQUID1186
69367-323-16Acetaminophen473 mL in 1 BOTTLE, PLASTICLIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-323-04ML - Milliliter69367-3231487bbd4-bc3f-4001-8463-bb79d06ce05512021-07-15
69367-323-16ML - Milliliter69367-3232f44c9ce-a538-45d0-924d-9e97b20b854012021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-323ACETAMINOPHEN LIQUID [WESTMINSTER PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20231216_ace5ebac-ec11-4c26-b1e3-954b450ee671.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 53 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
St. Joseph Chewable Low Dose AspirinASPIRINFoundation Consumer Healthcare LLC248cd302-e380-4837-bdae-9df620b67e8a2024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAAA Pharmaceutical, Inc.2d98e390-4f2a-41cc-b307-3d2f6a3700dd2024-12-02WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.409b5fcd-5880-4dda-85d8-26aeceb4f8ab2024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.c0c31523-c4c5-43c2-8d72-4d1456c720e92024-12-02WarningsExact identifier
application number: M013
NOTTS - Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLCe6754f62-e3b2-773f-e053-2a95a90ad36a2024-12-02WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.a891896d-c9fa-4448-915a-e6b531157d222024-12-02WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSAFEWAYd2d15e06-e9eb-3d2b-e053-2995a90a1cec2024-12-02WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENTopCo Associates LLCc2d33352-431c-4683-a4fa-a54437e7b8d22024-12-02WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENTopCo Associates LLCbdb01b3e-ad34-4003-9b9a-e83a2c0e90bb2024-12-02WarningsExact identifier
application number: M013
Aspirin 81mg Adult Low DoseASPIRINTopCare14d010fb-c4a1-4c3d-942f-58719727bfc02024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS Pharmacy, Incc4473ee6-4e01-1ec2-e053-2995a90ac5132024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINProficient Rx LP9c186289-e309-45e8-8934-1d0eae0375c22024-12-01WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP22f63d62-c941-5b8f-e063-6394a90aeecd2024-11-28WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a7b6318-b7d6-31b1-e053-2991aa0abf252024-11-28WarningsExact identifier
application number: M013
Extra Strength Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLINGLES MARKETS, INC.27fd288e-c07a-617f-e063-6394a90a17a42024-11-28WarningsExact identifier
application number: M013
BAYER Aspirin Original, TRAVEL BASIXASPIRINLil' Drug Store Products, Inc.7f5d9ebe-8119-49a2-9380-eca18a5e5e852024-11-27WarningsExact identifier
application number: M013
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEJones Healthcare Group - Packaging Services, Incc4168e4d-3dfc-4e51-a32e-14704cb59c662024-11-27WarningsExact identifier
application number: M013
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain ReliefACETAMINOPHEN, LIDOCAINE, MENTHOLKenvue Brands LLC2611e984-0dd5-bda1-e063-6394a90a559a2024-11-26WarningsExact identifier
application number: M013
First Aid Only Extra-Strength Non-AspirinACETAMINOPHENAcme United Corporation6891d57a-10a6-53de-e053-2a91aa0ac7c22024-11-26WarningsExact identifier
application number: M013
Chewable AspirinASPIRINMARC GLASSMAN, INC.c8314910-71ff-5a55-e053-2995a90aafc72024-11-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNace5ebac-ec11-4c26-b1e3-954b450ee6716
307675acetaminophen 32 MG/ML Oral SolutionSCDace5ebac-ec11-4c26-b1e3-954b450ee6716
307675acetaminophen 160 MG per 5 ML Oral SolutionSYace5ebac-ec11-4c26-b1e3-954b450ee6716
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYace5ebac-ec11-4c26-b1e3-954b450ee6716
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYace5ebac-ec11-4c26-b1e3-954b450ee6716
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYace5ebac-ec11-4c26-b1e3-954b450ee6716
307675APAP 32 MG/ML Oral SolutionSYace5ebac-ec11-4c26-b1e3-954b450ee6716
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN1e223faa-f6d0-4235-bc4c-6cfca84a5b0a3
307675acetaminophen 32 MG/ML Oral SolutionSCD1e223faa-f6d0-4235-bc4c-6cfca84a5b0a3
307675acetaminophen 160 MG per 5 ML Oral SolutionSY1e223faa-f6d0-4235-bc4c-6cfca84a5b0a3
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY1e223faa-f6d0-4235-bc4c-6cfca84a5b0a3
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY1e223faa-f6d0-4235-bc4c-6cfca84a5b0a3
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY1e223faa-f6d0-4235-bc4c-6cfca84a5b0a3
307675APAP 32 MG/ML Oral SolutionSY1e223faa-f6d0-4235-bc4c-6cfca84a5b0a3
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN402c8563-b14b-453f-80bc-4275f1c737022
307675acetaminophen 32 MG/ML Oral SolutionSCD402c8563-b14b-453f-80bc-4275f1c737022
307675acetaminophen 160 MG per 5 ML Oral SolutionSY402c8563-b14b-453f-80bc-4275f1c737022
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY402c8563-b14b-453f-80bc-4275f1c737022
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY402c8563-b14b-453f-80bc-4275f1c737022
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY402c8563-b14b-453f-80bc-4275f1c737022
307675APAP 32 MG/ML Oral SolutionSY402c8563-b14b-453f-80bc-4275f1c737022
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNecf95a39-7b34-560b-e053-2a95a90af2ac1
307675acetaminophen 32 MG/ML Oral SolutionSCDecf95a39-7b34-560b-e053-2a95a90af2ac1
307675acetaminophen 160 MG per 5 ML Oral SolutionSYecf95a39-7b34-560b-e053-2a95a90af2ac1
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYecf95a39-7b34-560b-e053-2a95a90af2ac1
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYecf95a39-7b34-560b-e053-2a95a90af2ac1
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYecf95a39-7b34-560b-e053-2a95a90af2ac1
307675APAP 32 MG/ML Oral SolutionSYecf95a39-7b34-560b-e053-2a95a90af2ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-323-0469367032304118 mL in 1 BOTTLE, PLASTIC (69367-323-04) 118 ml2021-05-050000-00-00NoNoCurrent