FDA.reportPublic FDA data

Medi-First Ibuprofen

Product NDC
47682-718
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

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 Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965, 900434, 900438

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-718-1347682071813250 PACKET in 1 BOX (47682-718-13) / 2 TABLET, COATED in 1 PACKET (47682-718-99) 250 packet2017-01-260000-00-00NoNoCurrent
47682-718-30476820718304 PACKET in 1 BOX (47682-718-30) / 2 TABLET, COATED in 1 PACKET4 packet2017-01-260000-00-00NoNoCurrent
47682-718-334768207183350 PACKET in 1 BOX (47682-718-33) / 2 TABLET, COATED in 1 PACKET50 packet2017-01-260000-00-00NoNoCurrent
47682-718-4847682071848125 PACKET in 1 BOX (47682-718-48) / 2 TABLET, COATED in 1 PACKET125 packet2017-01-260000-00-00NoNoCurrent
47682-718-504768207185025 PACKET in 1 BOX (47682-718-50) / 2 TABLET, COATED in 1 PACKET25 packet2019-04-160000-00-00NoNoCurrent
47682-718-99476820718992 TABLET, COATED in 1 PACKET (47682-718-99) 2017-01-26NoNoCurrent