FDA.reportPublic FDA data

CounterAct

Product NDC
54473-306
11-digit product format
544730306
Labeler code
54473
Product ID
54473-306_4d4001f1-0e22-4f9a-e063-6394a90ae123
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Melaleuca, Inc
Application
ANDA072096
Marketing category
ANDA
Marketing start
2023-08-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CounterAct
Brand name suffix
IB
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965, 1101919

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
54473-306-50CounterActIB1 in 1 BOXTABLET, COATED15
54473-306-50CounterActIB50 in 1 BOTTLETABLET, COATED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-306COUNTERACT IB (IBUPROFEN) TABLET, COATED [MELALEUCA, INC]4Current NDC, Legacy NDC, 2 package rows20240809_7fafc13e-3fee-ace3-e053-2a91aa0ac2ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101919Counteract IB 200 MG Oral TabletPSN7fafc13e-3fee-ace3-e053-2a91aa0ac2ea5
310965ibuprofen 200 MG Oral TabletPSN7fafc13e-3fee-ace3-e053-2a91aa0ac2ea5
1101919ibuprofen 200 MG Oral Tablet [Counteract IB]SBD7fafc13e-3fee-ace3-e053-2a91aa0ac2ea5
310965ibuprofen 200 MG Oral TabletSCD7fafc13e-3fee-ace3-e053-2a91aa0ac2ea5
1101919Counteract IB 200 MG Oral TabletSY7fafc13e-3fee-ace3-e053-2a91aa0ac2ea5
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY7fafc13e-3fee-ace3-e053-2a91aa0ac2ea5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-306-50544730306501 BOTTLE in 1 BOX (54473-306-50) / 50 TABLET, COATED in 1 BOTTLE1 bottle2023-08-140000-00-00NoNoCurrent