Cough and Cold HBP

Product NDC
50804-689
11-digit product format
508040689
Labeler code
50804
Product ID
50804-689_dee60eb6-3d0e-44a7-af38-3f9e629ab19b
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Geiss, Destin & Dunn Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-10
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
4; 30 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
Cough and Cold HBP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, 9D2RTI9KYH
Rxcui1421985

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-689-21Cough and Cold HBP2 in 1 CARTONTABLET, FILM COATED23
50804-689-21Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED83

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-689-21EA - Each50804-689712f78de-dab4-4d94-ab3b-3454cf79b00c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-689COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [GEISS, DESTIN & DUNN INC.]2Current NDC, 2 package rows20240913_1ea07a01-8779-48c2-a287-b7be866cce7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421985chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Oral TabletPSN1ea07a01-8779-48c2-a287-b7be866cce7b3
1421985chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Oral TabletSCD1ea07a01-8779-48c2-a287-b7be866cce7b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50804-689-21508040689212 BLISTER PACK in 1 CARTON (50804-689-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-09-10NoNoCurrent