FDA.reportPublic FDA data

Mucus Relief Extended Release

Product NDC
0363-0931
11-digit product format
003630931
Labeler code
0363
Product ID
0363-0931_1f23481e-89df-4c62-9712-6c9ace91bcbf
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA207342
Marketing category
ANDA
Marketing start
2018-08-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief Extended Release
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0363-0931-10Mucus Relief Extended Release1 in 1 BLISTER PACKTABLET15
0363-0931-10Mucus Relief Extended Release100 in 1 CARTONTABLET1005
0363-0931-20Mucus Relief Extended Release20 in 1 CARTONTABLET205
0363-0931-20Mucus Relief Extended Release1 in 1 BLISTER PACKTABLET15
0363-0931-40Mucus Relief Extended Release40 in 1 CARTONTABLET405
0363-0931-40Mucus Relief Extended Release1 in 1 BLISTER PACKTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0931-10EA - Each0363-0931d470bc76-abe5-4d79-8a04-8401e668134712022-06-06
0363-0931-20EA - Each0363-0931deed8036-fb24-49a4-a445-60667f9fb22212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0931MUCUS RELIEF EXTENDED RELEASE (GUAIFENESIN) TABLET [WALGREENS]5Current NDC, Legacy NDC, 6 package rows20220527_0ea23f92-eda7-49da-bc62-3085dbb4dc0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN0ea23f92-eda7-49da-bc62-3085dbb4dc0d5
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD0ea23f92-eda7-49da-bc62-3085dbb4dc0d5
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY0ea23f92-eda7-49da-bc62-3085dbb4dc0d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0931-1000363093110100 BLISTER PACK in 1 CARTON (0363-0931-10) / 1 TABLET in 1 BLISTER PACK100 blister pack2018-08-310000-00-00NoNoCurrent
0363-0931-200036309312020 BLISTER PACK in 1 CARTON (0363-0931-20) / 1 TABLET in 1 BLISTER PACK20 blister pack2018-08-310000-00-00NoNoCurrent
0363-0931-400036309314040 BLISTER PACK in 1 CARTON (0363-0931-40) / 1 TABLET in 1 BLISTER PACK40 blister pack2018-08-310000-00-00NoNoCurrent