FDA.reportPublic FDA data

12 Hour Mucus Relief

Product NDC
63868-149
11-digit product format
638680149
Labeler code
63868
Product ID
63868-149_2435b323-730e-a3fb-e063-6294a90a7498
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2021-09-17
Marketing end
2026-11-30
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
12 Hour Mucus Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-149-2012 Hour Mucus Relief10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE103
63868-149-2012 Hour Mucus Relief2 in 1 CARTONTABLET, EXTENDED RELEASE23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-149-20EA - Each63868-149854f85e8-0c0d-4713-a480-63841992641f12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-14912 HOUR MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]3Current NDC, Legacy NDC, 2 package rows20241013_0d3b8e23-90d2-431b-a395-a9ddf2457e64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN0d3b8e23-90d2-431b-a395-a9ddf2457e643
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD0d3b8e23-90d2-431b-a395-a9ddf2457e643
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY0d3b8e23-90d2-431b-a395-a9ddf2457e643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-149-20638680149202 BLISTER PACK in 1 CARTON (63868-149-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2021-09-172026-11-30NoNoCurrent