FDA.reportPublic FDA data

Cold and Sinus

Product NDC
53942-515
11-digit product format
539420515
Labeler code
53942
Product ID
53942-515_b2c93822-291f-4839-a6fd-9b515a8965a9
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
DeMoulas Market Basket
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-19
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 400; 10 mg/20mL; mg/20mL; mg/20mL
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
Cold and Sinus
Brand name suffix
Maxium Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 495W7451VQ, 04JA59TNSJ
Rxcui1116568

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
53942-515-25Cold and SinusMaxium Strength177 mL in 1 BOTTLELIQUID1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-515COLD AND SINUS MAXIUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DEMOULAS MARKET BASKET]2Current NDC, Legacy NDC, 1 package rows20231230_6e5ca8e1-5a03-4e77-b385-d44387fb3bfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116568acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2
1116568acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2
1116568acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2
1116568acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2
1116568APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2
1116568APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-515-2553942051525177 mL in 1 BOTTLE (53942-515-25) 177 ml2013-09-190000-00-00NoNoCurrent