FDA.reportPublic FDA data

Guaifenesin

Product NDC
49035-074
11-digit product format
490350074
Labeler code
49035
Product ID
49035-074_214ad45b-647b-44d4-8e5d-b2f57687d57a
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
WALMART STORES, INC.
Application
NDA021282
Marketing category
NDA
Marketing start
2017-12-10
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
1200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
49035-074-282021-01-29C16284748780-1ba0f9c33-1d2d-a910-e053-dadaa90a0b85GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg 28ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-074-28Guaifenesin Extended Release14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
49035-074-28Guaifenesin Extended Release2 in 1 CARTONTABLET, EXTENDED RELEASE23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-074-28EA - Each49035-0747044b2c7-1f5a-4c1a-9c2e-1284b3c9ac6f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-074GUAIFENESIN EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [WALMART STORES, INC.]3Legacy NDC, 2 package rows20190620_849c50f0-97bf-4f6a-b9f7-aa775ec8952d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN849c50f0-97bf-4f6a-b9f7-aa775ec8952d3
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD849c50f0-97bf-4f6a-b9f7-aa775ec8952d3
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY849c50f0-97bf-4f6a-b9f7-aa775ec8952d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49035-074-284903500742814 in 1 BLISTER PACKHistorical