FDA.reportPublic FDA data

Freds Chest Congestion Relief

Product NDC
10956-761
11-digit product format
109560761
Labeler code
10956
Product ID
10956-761_7a7843e4-292f-4bcf-8dfb-d0973f3407aa
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Reese Pharmaceutical Co
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-11-30
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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
10956-761-012020-01-31C16284748780-19d75b9d0-1402-f424-e053-dadaa90a57cedrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-761-01Freds Chest Congestion ReliefDM1 in 1 CARTONTABLET1126
10956-761-50Freds Chest Congestion ReliefDM50 in 1 BOTTLE, PLASTICTABLET50126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10956-761-50EA - Each10956-7610b71f6f4-7473-4c55-bd2a-472905e35bf212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHFREDS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]126
GuaifenesinACTIVE INGREDIENT495W7451VQFREDS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]126
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSFREDS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]126
GuaifenesinACTIVE MOIETY495W7451VQFREDS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-761FREDS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]126Legacy NDC, 2 package rows20100803_98e6d6ba-4164-4a14-b186-a5016c7e4c33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN98e6d6ba-4164-4a14-b186-a5016c7e4c33126
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD98e6d6ba-4164-4a14-b186-a5016c7e4c33126
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY98e6d6ba-4164-4a14-b186-a5016c7e4c33126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10956-761-01109560761011 in 1 CARTONHistorical
10956-761-501095607615050 in 1 BOTTLE, PLASTICHistorical