FDA.reportPublic FDA data

Medique at Home APAP Extra Strength

Product NDC
47682-043
Requested package NDC
47682-043-33
11-digit product format
476820043
Labeler code
47682
Product ID
47682-043_da6cfaeb-5a0f-3682-e053-2995a90a3639
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage47682-04347682-043-33DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
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e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-043-33Medique at Home APAP Extra Strength50 in 1 BOXTABLET, FILM COATED5010
47682-043-33Medique at Home APAP Extra Strength2 in 1 PACKETTABLET, FILM COATED210

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGUnifirst First Aid Corporationb56b4110-fb8f-e5a0-e053-2995a90a0ad32025-09-08WarningsExact identifier
ndc (package): 47682-043-33
ndc (product): 47682-043
ndc11 (package): 47682004333

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb56b4110-fb8f-e5a0-e053-2995a90a0ad310
198440acetaminophen 500 MG Oral TabletSCDb56b4110-fb8f-e5a0-e053-2995a90a0ad310
198440APAP 500 MG Oral TabletSYb56b4110-fb8f-e5a0-e053-2995a90a0ad310
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
198440acetaminophen 500 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN5d185f23-8af6-4e36-b514-5662986520a51
308761bismuth subsalicylate 262 MG Chewable TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 1 % Topical CreamPSN5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG 24HR Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
995666meclizine HCl 25 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
198440acetaminophen 500 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD5d185f23-8af6-4e36-b514-5662986520a51
308761bismuth subsalicylate 262 MG Chewable TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG Chewable TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
995666meclizine hydrochloride 25 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
198440APAP 500 MG Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 1 % Topical CreamSY5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG 24 HR Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-043-334768200433350 PACKET in 1 BOX (47682-043-33) > 2 TABLET, FILM COATED in 1 PACKET50 packet2021-02-010000-00-00NoNoCurrent