FDA.reportPublic FDA data

MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM

Product NDC
68210-4107
11-digit product format
682104107
Labeler code
68210
Product ID
68210-4107_eea1e5d0-4dbd-dc8f-e053-2a95a90af362
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Guaifenesin
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4107IInactivated by FDA2026-09-14
excluded packagepackage68210-410768210-4107-1IInactivated by FDA2026-09-14

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4107-1MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM10 in 1 BLISTER PACKCAPSULE, GELATIN COATED105
68210-4107-1MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM1 in 1 CARTONCAPSULE, GELATIN COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4107MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241215_db9a3b3c-8de2-4e06-84a3-ba1d52255c05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSNdb9a3b3c-8de2-4e06-84a3-ba1d52255c055
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCDdb9a3b3c-8de2-4e06-84a3-ba1d52255c055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4107-1682104107011 BLISTER PACK in 1 CARTON (68210-4107-1) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK1 blister pack2020-07-300000-00-00NoNoCurrent