FDA.reportPublic FDA data

Multi-Symptom PMS Relief

Product NDC
51316-679
11-digit product format
513160679
Labeler code
51316
Product ID
51316-679_e94add3f-a391-42e9-b71d-6db942292f7f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Pamabrom, Pyrilamine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M027
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-03
Substance
ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE
Active strength
500; 25; 15 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Multi-Symptom PMS Relief
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81ef39e2-b91e-4d34-b594-4ba557cc319bAvailable on FDA.report

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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diurex UltraCAFFEINEKobayashi Healthcare International, Inc.9a035265-40c6-43f5-8de6-6bece84498402025-04-14WarningsExact identifier
application number: M027
Diurex MaxPAMABROMKobayashi Healthcare International, Inc.37dfece3-d570-4ab2-ba95-af6eb1f3acd42025-04-11WarningsExact identifier
application number: M027
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEBayer HealthCare LLC.ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3242025-04-10WarningsExact identifier
application number: M027
Diurex Water PillsCAFFEINE, MAGNESIUM SALICYLATEKobayashi Healthcare International, Inc.e02a39f9-1c8c-4d38-b394-3f5b7062932c2025-04-10WarningsExact identifier
application number: M027
Cramp TabsACETAMINOPHEN, PAMABROM, AND PYRILAMINE MALEATEJHK DBA American Safety & First Aidc090807d-03b7-42d4-be41-f6240a3b330f2024-10-04WarningsExact identifier
application number: M027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-679-27513160679271 BOTTLE, PLASTIC in 1 CARTON (51316-679-27) / 32 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2026-06-03NoNoCurrent