FDA.reportPublic FDA data

Head Congestion and Mucus

Product NDC
70000-0083
11-digit product format
700000083
Labeler code
70000
Product ID
70000-0083_29e1f973-910c-4de5-9360-dde43eca2b11
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-11
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 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
Head Congestion and Mucus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 495W7451VQ, 04JA59TNSJ
Rxcui1243679

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0083-1Head Congestion and Mucus2 in 1 CARTONTABLET, FILM COATED29
70000-0083-1Head Congestion and Mucus12 in 1 BLISTER PACKTABLET, FILM COATED129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0083-1EA - Each70000-00835e198370-6dd7-408a-992a-2d4747d0498012022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0083HEAD CONGESTION AND MUCUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]8Current NDC, Legacy NDC, 2 package rows20240704_7418d92d-a540-40d6-91d0-b7eb1f87f8ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN7418d92d-a540-40d6-91d0-b7eb1f87f8ff9
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD7418d92d-a540-40d6-91d0-b7eb1f87f8ff9
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY7418d92d-a540-40d6-91d0-b7eb1f87f8ff9
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY7418d92d-a540-40d6-91d0-b7eb1f87f8ff9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0083-1700000083012 BLISTER PACK in 1 CARTON (70000-0083-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2021-03-110000-00-00NoNoCurrent