FDA.reportPublic FDA data

Refenesen Chest Congestion Relief

Product NDC
10956-788
11-digit product format
109560788
Labeler code
10956
Product ID
10956-788_8c2f21fe-dc31-4c4d-9350-f80570271bf2
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Reese Pharmaceutical Co
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-09-23
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
400 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
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
10956-788-012020-01-31C16284748780-19d75b9d0-b50f-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-788-01Refenesen Chest Congestion Relief1 in 1 CARTONTABLET11
10956-788-09Refenesen Chest Congestion Relief100 in 1 BOTTLE, PLASTICTABLET1001
10956-788-50Refenesen Chest Congestion Relief50 in 1 BOTTLE, PLASTICTABLET501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10956-788-09EA - Each10956-7885d9dc334-7a2b-4afa-a2d8-55a68cdd483612015-10-02
10956-788-50EA - Each10956-7885a8e1df3-6fd1-4111-8d52-c43a442170c012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQREFENESEN CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
GuaifenesinACTIVE MOIETY495W7451VQREFENESEN CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREFENESEN CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REFENESEN CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DREFENESEN CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
SILICON DIOXIDE, COLLOIDALINACTIVE INGREDIENTETJ7Z6XBU4REFENESEN CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREFENESEN CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-788REFENESEN CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1Legacy NDC, 3 package rows20101104_8a172972-d5dd-4c0e-8359-b5fd9edc96d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN8a172972-d5dd-4c0e-8359-b5fd9edc96d81
1086867Refenesen Chest Congestion Relief 400 MG Oral TabletPSN8a172972-d5dd-4c0e-8359-b5fd9edc96d81
1086867guaifenesin 400 MG Oral Tablet [Refenesen]SBD8a172972-d5dd-4c0e-8359-b5fd9edc96d81
359601guaifenesin 400 MG Oral TabletSCD8a172972-d5dd-4c0e-8359-b5fd9edc96d81
1086867Refenesen 400 MG Oral TabletSY8a172972-d5dd-4c0e-8359-b5fd9edc96d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10956-788-01109560788011 in 1 CARTONHistorical
10956-788-0910956078809100 in 1 BOTTLE, PLASTICHistorical
10956-788-501095607885050 in 1 BOTTLE, PLASTICHistorical