FDA.reportPublic FDA data

M-PAP

Product NDC
58657-525
11-digit product format
586570525
Labeler code
58657
Product ID
58657-525_41b5d614-1445-e68c-e063-6394a90ae714
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-01
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
M-PAP
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
3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0Available 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
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
58657-525-04M-PAP120 mL in 1 BOTTLELIQUID1206
58657-525-16M-PAP473 mL in 1 BOTTLELIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-525-04ML - Milliliter58657-52564573b7b-b406-4e75-a90e-4f58d9aa56d412019-09-05
58657-525-16ML - Milliliter58657-5256b398395-119f-4ccf-9f37-9fffa24d434112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-525M-PAP (ACETAMINOPHEN) LIQUID [METHOD PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20241126_3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNd344479b-80c1-4592-acc8-3f12690c839c106
307675acetaminophen 32 MG/ML Oral SolutionSCDd344479b-80c1-4592-acc8-3f12690c839c106
307675acetaminophen 160 MG per 5 ML Oral SolutionSYd344479b-80c1-4592-acc8-3f12690c839c106
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYd344479b-80c1-4592-acc8-3f12690c839c106
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYd344479b-80c1-4592-acc8-3f12690c839c106
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYd344479b-80c1-4592-acc8-3f12690c839c106
307675APAP 32 MG/ML Oral SolutionSYd344479b-80c1-4592-acc8-3f12690c839c106
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN31a41976-7f65-42d7-acf5-de9c2c5ca58e103
307675acetaminophen 32 MG/ML Oral SolutionSCD31a41976-7f65-42d7-acf5-de9c2c5ca58e103
307675acetaminophen 160 MG per 5 ML Oral SolutionSY31a41976-7f65-42d7-acf5-de9c2c5ca58e103
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY31a41976-7f65-42d7-acf5-de9c2c5ca58e103
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY31a41976-7f65-42d7-acf5-de9c2c5ca58e103
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY31a41976-7f65-42d7-acf5-de9c2c5ca58e103
307675APAP 32 MG/ML Oral SolutionSY31a41976-7f65-42d7-acf5-de9c2c5ca58e103
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNad01aea6-4af3-469b-b99d-e1e66aa40e8d101
307675acetaminophen 32 MG/ML Oral SolutionSCDad01aea6-4af3-469b-b99d-e1e66aa40e8d101
307675acetaminophen 160 MG per 5 ML Oral SolutionSYad01aea6-4af3-469b-b99d-e1e66aa40e8d101
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYad01aea6-4af3-469b-b99d-e1e66aa40e8d101
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYad01aea6-4af3-469b-b99d-e1e66aa40e8d101
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYad01aea6-4af3-469b-b99d-e1e66aa40e8d101
307675APAP 32 MG/ML Oral SolutionSYad01aea6-4af3-469b-b99d-e1e66aa40e8d101
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN3d1bb61c-15db-4eba-aba9-cfbcbc7b30e06
307675acetaminophen 32 MG/ML Oral SolutionSCD3d1bb61c-15db-4eba-aba9-cfbcbc7b30e06
307675acetaminophen 160 MG per 5 ML Oral SolutionSY3d1bb61c-15db-4eba-aba9-cfbcbc7b30e06
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY3d1bb61c-15db-4eba-aba9-cfbcbc7b30e06
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY3d1bb61c-15db-4eba-aba9-cfbcbc7b30e06
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY3d1bb61c-15db-4eba-aba9-cfbcbc7b30e06
307675APAP 32 MG/ML Oral SolutionSY3d1bb61c-15db-4eba-aba9-cfbcbc7b30e06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-525-0458657052504120 mL in 1 BOTTLE (58657-525-04) 120 ml2019-08-010000-00-00NoNoCurrent
58657-525-1658657052516473 mL in 1 BOTTLE (58657-525-16) 473 ml2019-08-010000-00-00NoNoCurrent