FDA.reportPublic FDA data

Mucus DM

Product NDC
11822-5050
Requested package NDC
11822-5050-6
11-digit product format
118225050
Labeler code
11822
Product ID
11822-5050_7e113199-c48e-471a-b55d-1677decac3f6
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Rite Aid Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-09-30
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/20mL; mg/20mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage11822-505011822-5050-6DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11822-505011822-5050-6IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11822-505011822-5050-6IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11822-505011822-5050-6IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-5050-62023-02-20C16284748780-1d6a99b39-6b0e-a426-e053-dadaa90af4c2Drug Facts
11822-5050-62022-01-28C16284748780-1d6a99b39-6b0e-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-5050-6Mucus DM177 mL in 1 BOTTLE, PLASTICLIQUID1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5050MUCUS DM (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RITE AID CORPORATION]3Legacy NDC, 1 package rows20240509_b1c9a009-92e7-4a85-b1b0-51d86156d882.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINRite Aid Corporationb1c9a009-92e7-4a85-b1b0-51d86156d8822025-11-20WarningsExact identifier
ndc (package): 11822-5050-6
ndc (product): 11822-5050
ndc11 (package): 11822505006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb1c9a009-92e7-4a85-b1b0-51d86156d8824
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb1c9a009-92e7-4a85-b1b0-51d86156d8824
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb1c9a009-92e7-4a85-b1b0-51d86156d8824
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb1c9a009-92e7-4a85-b1b0-51d86156d8824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-5050-611822505006177 mL in 1 BOTTLE, PLASTIC (11822-5050-6) 177 ml2019-09-300000-00-00NoNoCurrent