FDA.reportPublic FDA data

Select Brand Mucus Relief

Product NDC
15127-170
11-digit product format
151270170
Labeler code
15127
Product ID
15127-170_77f0990c-df64-42f6-b291-889049944454
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Select Brand Distributors
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-08-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
15127-170-502020-01-31C16284748780-19d75b9d0-f811-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15127-170-50Select Brand Mucus ReliefDM1 in 1 CARTONTABLET11
15127-170-50Select Brand Mucus ReliefDM50 in 1 BOTTLETABLET501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15127-170-50EA - Each15127-170af7d2f3c-bcc9-4886-a038-10b95ad7aa8012017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1
GuaifenesinACTIVE INGREDIENT495W7451VQSELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1
GuaifenesinACTIVE MOIETY495W7451VQSELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15127-170SELECT BRAND MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [SELECT BRAND DISTRIBUTORS ]1Legacy NDC, 2 package rows20140926_1ab81134-1e22-4d0f-975a-4df1022b24cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN1ab81134-1e22-4d0f-975a-4df1022b24cb1
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD1ab81134-1e22-4d0f-975a-4df1022b24cb1
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY1ab81134-1e22-4d0f-975a-4df1022b24cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
15127-170-50151270170501 in 1 CARTONHistorical