FDA.reportPublic FDA data

IBUPROFEN

Product NDC
50332-0152
11-digit product format
503320152
Labeler code
50332
Product ID
50332-0152_24531295-6ee5-4fcb-857b-50c3ea59e3c3
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
HART Health
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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
IBUPROFEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310965Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c1374e1-890f-48ab-8f93-e84da9d5bf84Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0152IBUPROFEN TABLET [HART HEALTH]3Current NDC20240126_1c1374e1-890f-48ab-8f93-e84da9d5bf84.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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relieving Cream with Menthol 10%MENTHOL 10% CREAMONE2ZEE LIMITED LIABILITY COMPANYae09e93f-3988-4477-ae53-b2f3df9769fb2025-05-05WarningsExact identifier
application number: M
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.edf07b7f-46fb-4915-b2ea-83d852617f602025-04-10WarningsExact identifier
application number: M
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb6559fb9-2dea-49c0-a274-3e77741a0ffd2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLdeecdb72-4cdb-4d6f-972f-a425a91afa5a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLdffdfa2c-a52e-4606-9b07-c8993e499f092025-03-23WarningsExact identifier
application number: M
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRL1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH KIDSDEXTROMETHORPHAN HBR-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb0fd2f2f-5cc4-4813-8f99-c78fbe8986562025-03-13WarningsExact identifier
application number: M
Menthol Pain Relief Gel PatchMENTHOL PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANYeab185d6-2a54-489d-8114-fe8088624ba42025-03-04WarningsExact identifier
application number: M
Lidocaine 4% Pain Relief Gel PatchLIDOCAINE 4% PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANY8e5a4ef4-b928-44b3-842c-92f1531af75b2025-03-03WarningsExact identifier
application number: M
gas reliefSIMETHICONEStrategic Sourcing Services LLC23005295-c5f2-4a76-8431-4a9b8d817d4d2025-01-03WarningsExact identifier
application number: M
Foster and Thrive infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
application number: M
BRONCOCHEM COLD AND FLU TEAACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLb7d3f54e-59ef-4b85-a88d-b053058dc1f62024-12-12WarningsExact identifier
application number: M
HYSAN PAIN RELIEVERMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDbad73234-c204-40a8-8176-45c75ae500c82024-10-07WarningsExact identifier
application number: M
HYSAN ANALGESICMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTD99a13b0a-1d77-479e-ba99-2cfa638de3392024-10-04WarningsExact identifier
application number: M
HYSAN HUO LU MEDICATEDMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDfe9eeaff-fcbf-4287-9f17-bcf1822bf35b2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO MEDICATEDMETHYL SALICYLATEHYSAN PHARMACEUTICAL CO LTDb84c4d33-5a77-46e0-b04e-32f73967bd1c2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO HUO LUMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDcd2288c4-9909-43c1-91da-b15545b097882024-10-04WarningsExact identifier
application number: M
CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-freeALUMINUM CHLOROHYDRATELaboratoires Clarins412116a1-f9af-4c03-85e0-aad5738dd7972024-08-05WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRL1a3ed214-e09b-4266-b68b-39e7c3127d262024-04-22WarningsExact identifier
application number: M
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN1c1374e1-890f-48ab-8f93-e84da9d5bf843
310965ibuprofen 200 MG Oral TabletSCD1c1374e1-890f-48ab-8f93-e84da9d5bf843
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1c1374e1-890f-48ab-8f93-e84da9d5bf843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50332-0152-45033201520450 PACKET in 1 BOX, UNIT-DOSE (50332-0152-4) / 2 TABLET in 1 PACKET50 packet2023-01-01NoNoCurrent
50332-0152-750332015207125 PACKET in 1 BOX, UNIT-DOSE (50332-0152-7) / 2 TABLET in 1 PACKET125 packet2023-01-01NoNoCurrent
50332-0152-850332015208250 PACKET in 1 BOX, UNIT-DOSE (50332-0152-8) / 2 TABLET in 1 PACKET250 packet2023-01-01NoNoCurrent