FDA.reportPublic FDA data

Ibuprofen 200 mg

Product NDC
70264-044
11-digit product format
702640044
Labeler code
70264
Product ID
70264-044_43c91095-a66c-e178-e063-6294a90ad4c1
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
R J General Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-05
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 200 mg
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
310964Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c7221ae-52d1-4d18-b586-c47ff656150dAvailable 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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-044-01Ibuprofen 200 mg25 in 1 CARTONCAPSULE, LIQUID FILLED252
70264-044-01Ibuprofen 200 mg2 in 1 POUCHCAPSULE, LIQUID FILLED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-044IBUPROFEN 200 MG (IBUPROFEN) CAPSULE, LIQUID FILLED [R J GENERAL CORPORATION]1Current NDC, 2 package rows20241116_1c7221ae-52d1-4d18-b586-c47ff656150d.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 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare infants pain and feverACETAMINOPHENTopco Associates LLCa1145ac3-3e55-4bd5-a53e-6cf869add9a12024-07-02WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRINDiscount Drug Mart Inc1c35f394-a221-6531-e063-6394a90acb8a2024-07-01WarningsExact identifier
application number: M013
AspirinASPIRINWildman Business Groupcdbfcf14-8685-40a9-9778-a3b4329dc1ad2024-07-01WarningsExact identifier
application number: M013
Back Pain Relief Extra Strength DoansMAGNESIUM SALICYLATEWildman Business Group2e17664f-a83f-48d1-8b2b-37f41eea65b62024-07-01WarningsExact identifier
application number: M013
Meijer Effervescent Pain ReliefASPIRINMeijer Distribution Inc17553911-e0fc-e355-e063-6394a90af7b82024-06-28WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4fb4f4b2-c238-4933-b874-08def3b34a282024-06-26WarningsExact identifier
application number: M013
good neighbor pharmacy pain and fever childrensACETAMINOPHENAmerisource Bergenca0833ef-837b-47dc-8676-e016af96622c2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4a030c3e-8104-4a0a-98c5-6ab469451f202024-06-26WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPadagis Israel Pharmaceuticals Ltda426dd82-b2d6-405e-b0af-cfb1310a6e192024-06-26WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALMART INC. (see also Equate)7d86a03f-74f4-4b24-b6a6-8747acfe905e2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader5bcc5da9-7e64-4308-a5be-2f47a8ca774d2024-06-25WarningsExact identifier
application number: M013
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINNuCare Pharmaceuticals,Inc.9e691264-d48a-6b48-e053-2995a90a93522024-06-20WarningsExact identifier
application number: M013
AspirinREGULAR STRENGTH ENTERIC COATED ASPIRINNuCare Pharmceuticals,Inc.a0705f4f-55cb-214a-e053-2995a90aa6802024-06-20WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MGLil' Drug Store Products, Inc.ee8e0e79-4da4-101f-e053-2a95a90a30a42024-06-19WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.b3a06e4b-0b31-4e2a-8dd1-9de85760477b2024-06-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Inc43c3fe72-a4ef-48a6-bc22-a644919c0c5c2024-06-17WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRETAIL BUSINESS SERVICES , LLC.093182a6-3ed8-5a3f-e063-6294a90a354a2024-06-14WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.093199be-e92a-6f60-e063-6294a90a85332024-06-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.09315a3d-bb2d-4f06-e063-6294a90a3bd32024-06-14WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC613bc633-0426-41a7-aea9-9ff56311b6072024-06-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN1c7221ae-52d1-4d18-b586-c47ff656150d2
310964ibuprofen 200 MG Oral CapsuleSCD1c7221ae-52d1-4d18-b586-c47ff656150d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70264-044-017026400440125 POUCH in 1 CARTON (70264-044-01) / 2 CAPSULE, LIQUID FILLED in 1 POUCH25 pouch2024-11-05NoNoCurrent