CounterAct

Product NDC
54473-134
11-digit product format
544730134
Labeler code
54473
Product ID
54473-134_8fe03304-24d2-48d5-8f51-c4db514f704d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Melaleuca, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-03-18
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-134-502020-01-31C16284748780-19d75b9d0-2071-f424-e053-dadaa90a57ceCounterAct IB Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-134-50CounterActIB50 in 1 BOTTLETABLET, FILM COATED503
54473-134-50CounterActIB1 in 1 BOXTABLET, FILM COATED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMCOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2COUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673COUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-134COUNTERACT IB (IBUPROFEN) TABLET, FILM COATED [MELALEUCA, INC.]3Legacy NDC, 2 package rows20110511_5c6f50e7-d309-4e47-9ee4-22503b00be3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101919Counteract IB 200 MG Oral TabletPSN5c6f50e7-d309-4e47-9ee4-22503b00be3e3
310965ibuprofen 200 MG Oral TabletPSN5c6f50e7-d309-4e47-9ee4-22503b00be3e3
1101919ibuprofen 200 MG Oral Tablet [Counteract IB]SBD5c6f50e7-d309-4e47-9ee4-22503b00be3e3
310965ibuprofen 200 MG Oral TabletSCD5c6f50e7-d309-4e47-9ee4-22503b00be3e3
1101919Counteract IB 200 MG Oral TabletSY5c6f50e7-d309-4e47-9ee4-22503b00be3e3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5c6f50e7-d309-4e47-9ee4-22503b00be3e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54473-134-505447301345050 in 1 BOTTLEHistorical