FDA.reportPublic FDA data

Robitussin 12 Hour Cough Relief

Product NDC
0031-8655
11-digit product format
000318655
Labeler code
0031
Product ID
0031-8655_159a0a07-055f-e1e2-e063-6394a90a9a37
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
ANDA091135
Marketing category
ANDA
Marketing start
2015-07-01
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
Robitussin 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8655-10Robitussin 12 Hour Cough Relief1 in 1 CARTONSUSPENSION, EXTENDED RELEASE17
0031-8655-10Robitussin 12 Hour Cough Relief89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE897

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8655-10ML - Milliliter0031-8655f75f6acb-adbd-43d6-902c-0a5ec8a73c6d12019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
POLISTIREXINACTIVE INGREDIENT5H9W9GTW27ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
SUCROSEINACTIVE INGREDIENTC151H8M554ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
WATERINACTIVE INGREDIENT059QF0KO0RROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8655ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 2 package rows20240410_5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN5d12a1b8-f1fb-41ca-9a4f-0595a585cbb57
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD5d12a1b8-f1fb-41ca-9a4f-0595a585cbb57
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY5d12a1b8-f1fb-41ca-9a4f-0595a585cbb57
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY5d12a1b8-f1fb-41ca-9a4f-0595a585cbb57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8655-10000318655101 BOTTLE in 1 CARTON (0031-8655-10) / 89 mL in 1 BOTTLE1 bottle2015-07-010000-00-00NoNoCurrent