FDA.reportPublic FDA data

foster and thrive 12 hour cough relief

Product NDC
70677-1025
11-digit product format
706771025
Labeler code
70677
Product ID
70677-1025_584b1aff-834d-49f4-8056-b339b7044135
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA091135
Marketing category
ANDA
Marketing start
2023-09-03
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
foster and thrive 12 hour cough relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1025-1foster and thrive 12 hour cough relief1 in 1 CARTONSUSPENSION, EXTENDED RELEASE13
70677-1025-1foster and thrive 12 hour cough relief89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE893

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1025-1ML - Milliliter70677-10254e1c3839-baf9-4e4f-8ee9-ef603ed2919212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1025FOSTER AND THRIVE 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20230913_db2e79f7-827f-45da-85ba-f3a774251070.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNdb2e79f7-827f-45da-85ba-f3a7742510703
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDdb2e79f7-827f-45da-85ba-f3a7742510703
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYdb2e79f7-827f-45da-85ba-f3a7742510703
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYdb2e79f7-827f-45da-85ba-f3a7742510703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1025-1706771025011 BOTTLE in 1 CARTON (70677-1025-1) / 89 mL in 1 BOTTLE1 bottle2023-09-03NoNoHistorical