FDA.reportPublic FDA data

MUCUS RELIEF DM

Product NDC
68210-1930
Requested package NDC
68210-1930-4
11-digit product format
682101930
Labeler code
68210
Product ID
68210-1930_d218a518-aabc-4221-e053-2a95a90ab922
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-03-12
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
400 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage68210-193068210-1930-4IInactivated by FDA2026-10-12

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68210-1930-12023-12-08MUCUS RELIEF DM
68210-1930-42023-12-08MUCUS RELIEF DM
68210-1930-12023-01-30MUCUS RELIEF DM
68210-1930-42023-01-30MUCUS RELIEF DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-1930-1MUCUS RELIEF DM1 in 1 CARTONCAPSULE, LIQUID FILLED17
68210-1930-1MUCUS RELIEF DM10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED107
68210-1930-4MUCUS RELIEF DM4 in 1 CARTONCAPSULE, LIQUID FILLED47
68210-1930-4MUCUS RELIEF DM10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-1930MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]7Legacy NDC, 4 package rows20241215_6b2f3214-106a-405c-a55e-500c8dba86f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661740dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral CapsulePSN6b2f3214-106a-405c-a55e-500c8dba86f27
1661740dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral CapsuleSCD6b2f3214-106a-405c-a55e-500c8dba86f27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-1930-4682101930044 BLISTER PACK in 1 CARTON (68210-1930-4) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2020-03-120000-00-00NoNoCurrent