FDA.reportPublic FDA data

Premsyn pms Premenstrual Pain Relief

Product NDC
71687-3102
11-digit product format
716873102
Labeler code
71687
Product ID
71687-3102_32bde825-4a2d-de16-e063-6394a90a7941
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Pamabrom and Pyrilamine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Focus Consumer Healthcare, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-13
Substance
ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE
Active strength
500; 25; 15 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71687-3102-4IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71687-3102-4IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71687-3102-4IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71687-3102-4IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71687-3102-4UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71687-3102-4UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71687-3102-4UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Premsyn pms Premenstrual Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
PAMABROM25 mg/1
PYRILAMINE MALEATE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
UA8U0KJM72Internal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1052637Internal RxNorm lookup
1052641Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b6f6260-69ae-cfeb-e053-2a91aa0a6b49Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71687-3102-42025-04-14C16284748780-12cef2736-8f8b-d83d-e063-dadaa90ab31fPremsyn pms Premenstrual Pain Relief
71687-3102-42025-01-30C16284748780-12cef2736-8f8b-d83d-e063-dadaa90ab31fPremsyn pms Premenstrual Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71687-3102-4Premsyn pms Premenstrual Pain Relief40 in 1 BOTTLE, PLASTICTABLET408
71687-3102-4Premsyn pms Premenstrual Pain Relief1 in 1 CARTONTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71687-3102PREMSYN PMS PREMENSTRUAL PAIN RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [FOCUS CONSUMER HEALTHCARE, LLC]8Current NDC, Legacy NDC, 2 package rows20250416_5b6f6260-69ae-cfeb-e053-2a91aa0a6b49.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 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
LOW DOSE ASPIRINASPIRINBryant Ranch Prepack64c28b38-23bb-4c7e-9c19-1d1f0d5975282024-01-18WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLCe0dd4c04-6811-38a1-e053-2995a90aa3c92024-01-17WarningsExact identifier
application number: M013
Regular Strength AcetaminophenACETAMINOPHENCARDINAL HEALTHbdf8c511-ce25-0e30-e053-2a95a90a33f62024-01-10WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052637acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletPSN5b6f6260-69ae-cfeb-e053-2a91aa0a6b498
1052641Premsyn PMS 500 MG / 25 MG / 15 MG Oral TabletPSN5b6f6260-69ae-cfeb-e053-2a91aa0a6b498
1052641acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet [Premsyn PMS]SBD5b6f6260-69ae-cfeb-e053-2a91aa0a6b498
1052637acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletSCD5b6f6260-69ae-cfeb-e053-2a91aa0a6b498
1052637APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral TabletSY5b6f6260-69ae-cfeb-e053-2a91aa0a6b498
1052641APAP 500 MG / pamabrom 25 MG / Pyrilamine Maleate 15 MG Oral Tablet [Premsyn PMS]SY5b6f6260-69ae-cfeb-e053-2a91aa0a6b498
1052641Premsyn PMS (APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG) Oral TabletSY5b6f6260-69ae-cfeb-e053-2a91aa0a6b498

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71687-3102-4716873102041 BOTTLE, PLASTIC in 1 CARTON (71687-3102-4) / 40 TABLET in 1 BOTTLE, PLASTIC2017-10-130000-00-00NoNoCurrent