FDA.reportPublic FDA data

Midol Bloat Relief

Product NDC
0280-0070
11-digit product format
002800070
Labeler code
0280
Product ID
0280-0070_452648e2-82a5-84f5-e063-6394a90a6df1
Type
HUMAN OTC DRUG
Nonproprietary name
pamabrom
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M027
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-28
Substance
PAMABROM
Active strength
50 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
Midol Bloat Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAMABROM50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UA8U0KJM72Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199158Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1ad6073-63f6-669f-e053-2995a90aaceeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0070-01Midol Bloat Relief60 in 1 BOTTLETABLET603
0280-0070-01Midol Bloat Relief1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0070MIDOL BLOAT RELIEF (PAMABROM) TABLET [BAYER HEALTHCARE LLC.]2Current NDC, 2 package rows20241210_c1ad6073-63f6-669f-e053-2995a90aacee.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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199158pamabrom 50 MG Oral TabletPSNc1ad6073-63f6-669f-e053-2995a90aacee3
199158pamabrom 50 MG Oral TabletSCDc1ad6073-63f6-669f-e053-2995a90aacee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0280-0070-01002800070011 BOTTLE in 1 CARTON (0280-0070-01) / 60 TABLET in 1 BOTTLE1 bottle2021-04-28NoNoCurrent