FDA.reportPublic FDA data

Guaifenesin

Product NDC
51660-566
11-digit product format
516600566
Labeler code
51660
Product ID
51660-566_4aa4fb35-6f33-6e33-e063-6394a90a495e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ohm Laboratories, Inc.
Application
ANDA209254
Marketing category
ANDA
Marketing start
2022-04-01
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621, 636522

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
51660-566-21Guaifenesin20 in 1 CARTONTABLET, EXTENDED RELEASE204
51660-566-41Guaifenesin40 in 1 CARTONTABLET, EXTENDED RELEASE404
51660-566-68Guaifenesin68 in 1 CARTONTABLET, EXTENDED RELEASE684

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-566GUAIFENESIN TABLET, EXTENDED RELEASE [OHM LABORATORIES, INC.]3Current NDC, Legacy NDC, 3 package rows20250424_7076e42a-17ff-4c42-9963-2dc02c0a5e49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN7076e42a-17ff-4c42-9963-2dc02c0a5e494
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN7076e42a-17ff-4c42-9963-2dc02c0a5e494
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD7076e42a-17ff-4c42-9963-2dc02c0a5e494
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD7076e42a-17ff-4c42-9963-2dc02c0a5e494
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY7076e42a-17ff-4c42-9963-2dc02c0a5e494
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY7076e42a-17ff-4c42-9963-2dc02c0a5e494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51660-566-215166005662120 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-21) 2022-04-010000-00-00NoNoCurrent
51660-566-415166005664140 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-41) 2022-04-010000-00-00NoNoCurrent
51660-566-685166005666868 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-68) 2026-01-17NoNoCurrent