FDA.reportPublic FDA data

Medi-First Ibuprofen

Product NDC
47682-718
Requested package NDC
47682-718-99
11-digit product format
476820718
Labeler code
47682
Product ID
47682-718_3e5d5179-6101-176d-e063-6394a90aed0c
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
ANDA079174
Marketing category
ANDA
Marketing start
2017-01-26
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079174-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2010-12-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENTWIN MED LLCf03958f8-aeae-edf0-e053-2a95a90a3e9e2026-07-22WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Ibuwin ForteIBUPROFENOPMX LLC0daf1be9-ea38-461e-e063-6394a90a79542026-07-15WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
WalgreensDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLWalgreen Co.5630f48b-404c-b847-e063-6394a90a8d8e2026-07-09WarningsExact identifier
ndc (package): 47682-718-99
ndc11 (package): 47682071899
Care ScienceDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, LIDOCAINE HCL, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, ETHYL ALCOHOLASO LLC562f2b2c-d234-e491-e063-6294a90a705f2026-07-08WarningsExact identifier
ndc (package): 47682-718-99
ndc11 (package): 47682071899
IbuprofenIBUPROFENDr. Reddy's Laboratories Inc.4d830b9b-b396-9581-7572-c7f19ff175972026-07-01WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.68988a5b-7a6a-4ecd-8006-f2610bac2ad72026-06-08WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENMedline industries, LP5d2482b4-cd90-4246-85a9-fd1d35315b6c2026-06-04WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENGrocery Outlet, Inc.441d762d-9022-426a-e063-6294a90a50762026-05-21WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IBUPROFEN 200 MGIBUPROFEN 200 MGFarmacias De Similares TX LLC441f7920-5666-5a3e-e063-6294a90a55832026-01-28WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENHYVEE INC45aead8a-37ee-9a66-e063-6394a90a5d172026-01-13WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Xpect IbuprofenIBUPROFENCintas Corporation976ba88a-6428-40d1-a2fd-eac64963ba1d2026-01-08WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Inc29190ebf-bb9c-4406-be7b-4427741aeb742025-12-23WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENCVS10424ad8-74fc-4f5f-e063-6394a90a13bd2025-12-23WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENGranules USA, Inc.8cb595d2-b7c2-687d-e053-2a95a90a57202025-12-22WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENRetail Business Services, LLC04115ec1-ef31-1746-e063-6394a90a0a522025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a567dc6f-bd83-b9f5-e053-2995a90a05ee2025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c17f-9766-deaa-e063-6394a90a8d602025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IBUPROFENIBUPROFENWALGREENS CO.b8a77b7e-e161-b3ac-e053-2995a90af3e82025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174

Additional Listing Data#

Finished product
Yes
Brand name base
Medi-First 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310965Internal RxNorm lookup
900434Internal RxNorm lookup
900438Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0607edb0-1b3a-2ccd-e054-00144ff8d46cAvailable 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-718-13Medi-First Ibuprofen250 in 1 BOXTABLET, COATED25025
47682-718-30Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-718-30Medi-First Ibuprofen4 in 1 BOXTABLET, COATED425
47682-718-33Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-718-33Medi-First Ibuprofen50 in 1 BOXTABLET, COATED5025
47682-718-48Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-718-48Medi-First Ibuprofen125 in 1 BOXTABLET, COATED12525
47682-718-50Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225
47682-718-50Medi-First Ibuprofen25 in 1 BOXTABLET, COATED2525
47682-718-99Medi-First Ibuprofen2 in 1 PACKETTABLET, COATED225

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMMEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
IbuprofenACTIVE MOIETYWK2XYI10QMMEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3
TRIACETININACTIVE INGREDIENTXHX3C3X673MEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-718MEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, COATED MEDIQUE IPRIN (IBUPROFEN) TABLET, COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID CORPORATION]24Current NDC, Legacy NDC, 10 package rows20240915_0607edb0-1b3a-2ccd-e054-00144ff8d46c.zip
47682-718CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC]2Current NDC, Legacy NDC20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900434Addaprin 200 MG Oral TabletPSN0607edb0-1b3a-2ccd-e054-00144ff8d46c25
310965ibuprofen 200 MG Oral TabletPSN0607edb0-1b3a-2ccd-e054-00144ff8d46c25
900438Ultraprin 200 MG Oral TabletPSN0607edb0-1b3a-2ccd-e054-00144ff8d46c25
900434ibuprofen 200 MG Oral Tablet [Addaprin]SBD0607edb0-1b3a-2ccd-e054-00144ff8d46c25
900438ibuprofen 200 MG Oral Tablet [Ultraprin]SBD0607edb0-1b3a-2ccd-e054-00144ff8d46c25
310965ibuprofen 200 MG Oral TabletSCD0607edb0-1b3a-2ccd-e054-00144ff8d46c25
900434Addaprin 200 MG Oral TabletSY0607edb0-1b3a-2ccd-e054-00144ff8d46c25
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY0607edb0-1b3a-2ccd-e054-00144ff8d46c25
900438Ultraprin 200 MG Oral TabletSY0607edb0-1b3a-2ccd-e054-00144ff8d46c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
47682-718-99476820718992 TABLET, COATED in 1 PACKET (47682-718-99) 2017-01-26NoNoCurrent