FDA.reportPublic FDA data

MAXIMUM STRENGTH CHEST CONGESTION AND COUGH

Product NDC
69842-783
Requested package NDC
69842-783-20
11-digit product format
698420783
Labeler code
69842
Product ID
69842-783_edc5838f-8af1-cd51-e053-2995a90a8206
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Guaifenesin
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
CVS PHARMACY, INC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-01-13
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-78369842-783-20IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-783-20MAXIMUM STRENGTH CHEST CONGESTION AND COUGH10 in 1 BLISTER PACKCAPSULE, GELATIN COATED106
69842-783-20MAXIMUM STRENGTH CHEST CONGESTION AND COUGH2 in 1 CARTONCAPSULE, GELATIN COATED26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-783-20EA - Each69842-7839a65f98c-dc70-4269-8a23-a37f864d9fce12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-783MAXIMUM STRENGTH CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [CVS PHARMACY, INC.]6Legacy NDC, 2 package rows20241220_3d9852cd-0a2b-4935-89dd-05da40b626fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN3d9852cd-0a2b-4935-89dd-05da40b626fd6
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD3d9852cd-0a2b-4935-89dd-05da40b626fd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-783-20698420783202 BLISTER PACK in 1 CARTON (69842-783-20) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK2 blister pack2021-01-130000-00-00NoNoCurrent