FDA.reportPublic FDA data

Pamabrom

Product NDC
35916-1654
11-digit product format
359161654
Labeler code
35916
Product ID
35916-1654_4958ad4c-0499-11f0-e063-6394a90a81d1
Type
HUMAN OTC DRUG
Nonproprietary name
Pamabrom
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Softgel Healthcare Pvt Ltd
Application
M027
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-21
Substance
PAMABROM
Active strength
50 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
Pamabrom
Listing expiration
2027-12-31

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
832080Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
186805ed-84fc-e723-e063-6294a90ad320Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-1654-1Pamabrom48 in 1 BOTTLECAPSULE, LIQUID FILLED482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35916-1654PAMABROM CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]1Current NDC, 1 package rows20240522_186805ed-84fc-e723-e063-6294a90ad320.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
832080pamabrom 50 MG Oral CapsulePSN186805ed-84fc-e723-e063-6294a90ad3202
832080pamabrom 50 MG Oral CapsuleSCD186805ed-84fc-e723-e063-6294a90ad3202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
35916-1654-13591616540148 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-1654-1) 2024-05-21NoNoCurrent