FDA.reportPublic FDA data

Medique APAP

Product NDC
47682-057
11-digit product format
476820057
Labeler code
47682
Product ID
47682-057_3e4cb995-be20-a159-e063-6294a90ae6e3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-27
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
Medique APAP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1

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
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04805d9c-d959-4870-a185-48b58a880880Available 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
47682-057-13Medique APAP250 in 1 BOXTABLET, COATED25026
47682-057-36Medique APAP75 in 1 BOXTABLET, COATED7526
47682-057-48Medique APAP125 in 1 BOXTABLET, COATED12526
47682-057-64Medique APAP12 in 1 BOXTABLET, COATED1226
47682-057-99Medique APAP2 in 1 PACKETTABLET, COATED226

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMEDIQUE APAP (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMEDIQUE APAP (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEDIQUE APAP (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMEDIQUE APAP (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EMEDIQUE APAP (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEDIQUE APAP (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDIQUE APAP (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMEDIQUE APAP (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-057MEDI-FIRST NON-ASPIRIN (ACETAMINOPHEN) TABLET, COATED MEDIQUE APAP (ACETAMINOPHEN) TABLET, COATED MEDI-FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, COATED MEDI FIRST PLUS NON-ASPIRIN (ACETAMINOPHEN) TABLET, COATED DOVER AMINOPHEN (ACETAMINOPHEN) TABLET, COATED DOVER AMINOFEN (ACETAMINOPHEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]25Current NDC, 5 package rows20250210_04805d9c-d959-4870-a185-48b58a880880.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 11 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MapapACETAMINOPHENMajor Pharmaceuticalsefec6af2-8b26-47f6-88c8-b0a6d69a2d7d2026-06-03WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIae3114c3-8cfe-4b81-8ac7-c281fe68b4622026-06-03WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCOSTCO WHOLESALE CORPORATION3745aa18-a711-43ed-9bc4-1f087b3c53c02026-06-03WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3f653262-b931-7d42-e063-6394a90adddd2026-06-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreen Company0b1bef50-7957-4ea1-9ae3-91f59ea2dbb42026-06-03WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.42310898-cf3a-4ffb-88bb-b8b84449156e2026-06-02WarningsExact identifier
application number: M013
PAIN RELIEFACETAMINOPHENMeijer, Inc.1319bab8-8f17-44fb-9d91-099b0ba38a8d2026-06-01WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)7a98d4d9-54e2-45c1-a76a-7f1907566e952026-06-01WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.58840cf4-aceb-c7cf-e063-6294a90a5ff42026-06-01WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacy832acd72-1dda-4490-978f-5f31748942df2026-06-01WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals786dbcd5-f5c2-4491-e053-2991aa0a34372026-05-29WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEMeijer Distribution Ince513f2d9-d591-4790-a117-6176ce2279dc2026-05-29WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader5460a4b7-5da3-4fc2-a565-0b0dd11bbf442026-05-29WarningsExact identifier
application number: M013
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf55d3663-7007-41cd-ae2d-5aca6311be812026-05-28WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5130c695-a80e-2dd3-e063-6294a90a404f2026-05-28WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC1622f694-4d63-4c56-8737-fae31f0ecfb72026-05-27WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLC257436e1-e0f3-4a87-bffe-4f176b836caf2026-05-27WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLC6509a545-0036-460a-8f0d-b31caae178552026-05-27WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
application number: M013
Pain and Fever Chewables ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbad8ac0a-518d-4639-9b92-a39e0d4372382026-05-22WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN04805d9c-d959-4870-a185-48b58a88088026
313782acetaminophen 325 MG Oral TabletSCD04805d9c-d959-4870-a185-48b58a88088026
313782APAP 325 MG Oral TabletSY04805d9c-d959-4870-a185-48b58a88088026
313782acetaminophen 325 MG Oral TabletPSN3ba5c802-fe5a-e42a-e063-6394a90ae67e1
313782acetaminophen 325 MG Oral TabletSCD3ba5c802-fe5a-e42a-e063-6394a90ae67e1
313782APAP 325 MG Oral TabletSY3ba5c802-fe5a-e42a-e063-6394a90ae67e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
47682-057-1347682005713250 PACKET in 1 BOX (47682-057-13) / 2 TABLET, COATED in 1 PACKET (47682-057-99) 250 packet2024-03-27NoNoCurrent
47682-057-364768200573675 PACKET in 1 BOX (47682-057-36) / 2 TABLET, COATED in 1 PACKET (47682-057-99) 75 packet2024-03-27NoNoCurrent
47682-057-4847682005748125 PACKET in 1 BOX (47682-057-48) / 2 TABLET, COATED in 1 PACKET (47682-057-99) 125 packet2024-03-27NoNoCurrent
47682-057-644768200576412 PACKET in 1 BOX (47682-057-64) / 2 TABLET, COATED in 1 PACKET (47682-057-99) 12 packet2024-03-27NoNoCurrent
47682-057-99476820057992 TABLET, COATED in 1 PACKET (47682-057-99) 2024-03-27NoNoCurrent