Dr. Simi Mucus Relief

Product NDC
85786-302
11-digit product format
857860302
Labeler code
85786
Product ID
85786-302_4ef7dae3-9082-bc3b-e063-6294a90a9a75
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Farmacias De Similares TX LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2026-04-08
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
Dr. Simi Mucus Relief
Listing expiration
2027-12-31

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
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
85786-302-40Dr. Simi Mucus Relief2 in 1 CARTONTABLET, EXTENDED RELEASE21
85786-302-40Dr. Simi Mucus Relief20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN4ef7dae3-9081-bc3b-e063-6294a90a9a751
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD4ef7dae3-9081-bc3b-e063-6294a90a9a751
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY4ef7dae3-9081-bc3b-e063-6294a90a9a751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85786-302-40857860302402 BLISTER PACK in 1 CARTON (85786-302-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2026-04-08NoNoHistorical