FDA.reportPublic FDA data

Mucus Relief D

Product NDC
69842-211
11-digit product format
698420211
Labeler code
69842
Product ID
69842-211_6325e827-fe80-4355-2e69-d4952b9e6030
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine HCL
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Health Corp
Application
ANDA208369
Marketing category
ANDA
Marketing start
2019-07-08
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
1200; 120 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 Relief D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 6V9V2RYJ8N
Rxcui1244675

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
69842-211-24Mucus Relief D4 in 1 CARTONTABLET, EXTENDED RELEASE47
69842-211-24Mucus Relief D6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE67
69842-211-28Mucus Relief D2 in 1 CARTONTABLET, EXTENDED RELEASE27
69842-211-28Mucus Relief D12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-211-24EA - Each69842-2116a2d4bff-f6c9-41da-a97e-725f52b5455412019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-211MUCUS RELIEF D (GUAIFENESIN AND PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [CVS HEALTH CORP]6Current NDC, Legacy NDC, 4 package rows20231011_19cde6f8-649a-df69-7ee9-05da2cccba5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN19cde6f8-649a-df69-7ee9-05da2cccba5b7
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD19cde6f8-649a-df69-7ee9-05da2cccba5b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-211-24698420211244 BLISTER PACK in 1 CARTON (69842-211-24) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2019-07-080000-00-00NoNoCurrent
69842-211-28698420211282 BLISTER PACK in 1 CARTON (69842-211-28) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2020-05-310000-00-00NoNoCurrent