FDA.reportPublic FDA data

MUCUS RELIEF DM

Product NDC
0363-9897
11-digit product format
003639897
Labeler code
0363
Product ID
0363-9897_c6247e44-2f91-7314-e053-2995a90a3e0e
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-15
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-9897DDiscontinued by firm2026-10-05
excluded packagepackage0363-98970363-9897-30DDiscontinued by firm2026-10-05

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-9897-302023-12-08C16284748780-1f386c64a-34d9-0266-e053-dadaa90a7c1aMUCUS RELIEF DM
0363-9897-302023-01-30C16284748780-1f386c64a-34d9-0266-e053-dadaa90a7c1aMUCUS RELIEF DM

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9897MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [WALGREENS]6Legacy NDC20241222_5acabc62-cc71-4675-8c6d-8e5d177604b7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9897-30003639897303 BLISTER PACK in 1 CARTON (0363-9897-30) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2018-04-180000-00-00NoNoCurrent