FDA.reportPublic FDA data

MEDI-FIRST Non-Aspirin Extra Strength

Product NDC
47682-804
11-digit product format
476820804
Labeler code
47682
Product ID
47682-804_3e4cc4d7-cd28-c745-e063-6294a90aa614
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-30
Substance
ACETAMINOPHEN
Active strength
500 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
MEDI-FIRST Non-Aspirin Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 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
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
56822785-d5fb-4869-971e-5de637c2eda8Available 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
47682-804-13MEDI-FIRST Non-Aspirin Extra Strength250 in 1 BOXTABLET, FILM COATED25020
47682-804-13MEDI-FIRST Non-Aspirin Extra Strength2 in 1 PACKETTABLET, FILM COATED220
47682-804-33MEDI-FIRST Non-Aspirin Extra Strength2 in 1 PACKETTABLET, FILM COATED220
47682-804-33MEDI-FIRST Non-Aspirin Extra Strength50 in 1 BOXTABLET, FILM COATED5020
47682-804-48MEDI-FIRST Non-Aspirin Extra Strength2 in 1 PACKETTABLET, FILM COATED220
47682-804-48MEDI-FIRST Non-Aspirin Extra Strength125 in 1 BOXTABLET, FILM COATED12520
47682-804-50MEDI-FIRST Non-Aspirin Extra Strength2 in 1 PACKETTABLET, FILM COATED220
47682-804-50MEDI-FIRST Non-Aspirin Extra Strength25 in 1 BOXTABLET, FILM COATED2520
47682-804-99MEDI-FIRST Non-Aspirin Extra Strength2 in 1 PACKETTABLET, FILM COATED220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-804-13EA - Each47682-804a72cd718-ed0d-42c4-a0ba-5b807f413c8312012-07-24
47682-804-33EA - Each47682-80408e01d85-84f3-4f5f-8628-4fddf1dfe47712012-07-24
47682-804-48EA - Each47682-80461d7ff7c-ea98-4bc9-afe1-4a4ab46c884012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-804MEDIQUE APAP EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED MEDI FIRST PLUS NON-ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]19Current NDC, Legacy NDC, 9 package rows20240329_56822785-d5fb-4869-971e-5de637c2eda8.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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN56822785-d5fb-4869-971e-5de637c2eda820
198440acetaminophen 500 MG Oral TabletSCD56822785-d5fb-4869-971e-5de637c2eda820
198440APAP 500 MG Oral TabletSY56822785-d5fb-4869-971e-5de637c2eda820
198440acetaminophen 500 MG Oral TabletPSN9071b047-5463-4f65-b775-bfb0ce0665274
198440acetaminophen 500 MG Oral TabletSCD9071b047-5463-4f65-b775-bfb0ce0665274
198440APAP 500 MG Oral TabletSY9071b047-5463-4f65-b775-bfb0ce0665274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-804-1347682080413250 PACKET in 1 BOX (47682-804-13) / 2 TABLET, FILM COATED in 1 PACKET250 packet2008-12-300000-00-00NoNoCurrent
47682-804-334768208043350 PACKET in 1 BOX (47682-804-33) / 2 TABLET, FILM COATED in 1 PACKET50 packet2008-12-300000-00-00NoNoCurrent
47682-804-4847682080448125 PACKET in 1 BOX (47682-804-48) / 2 TABLET, FILM COATED in 1 PACKET125 packet2008-12-300000-00-00NoNoCurrent
47682-804-504768208045025 PACKET in 1 BOX (47682-804-50) / 2 TABLET, FILM COATED in 1 PACKET25 packet2008-12-300000-00-00NoNoCurrent
47682-804-99476820804992 TABLET, FILM COATED in 1 PACKET (47682-804-99) 2008-12-300000-00-00NoNoCurrent