mucus D

Product NDC
0113-8307
11-digit product format
001138307
Labeler code
0113
Product ID
0113-8307_db6ada8a-1799-4d35-8bda-4a322fbd7a06
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin and pseudoephedrine hydrochloride
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA214407
Marketing category
ANDA
Marketing start
2025-10-03
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
600; 60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
mucus D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 6V9V2RYJ8N
Rxcui1305603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-8307-68mucus D18 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL181
0113-8307-68mucus D2 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-8307-68EA - Each0113-8307d1a97d0e-ebc0-4b91-9506-a67bacab21d112026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSNdb6ada8a-1799-4d35-8bda-4a322fbd7a061
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCDdb6ada8a-1799-4d35-8bda-4a322fbd7a061
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSYdb6ada8a-1799-4d35-8bda-4a322fbd7a061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-8307-68001138307682 BLISTER PACK in 1 CARTON (0113-8307-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-10-03NoNoHistorical