DRx Choice Childrens Stuffy Nose and Chest Congestion

Product NDC
68163-748
11-digit product format
681630748
Labeler code
68163
Product ID
68163-748_3fef0ee0-c60c-a9de-e063-6394a90a99d6
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Phenylephrine Hcl
Dosage form
SOLUTION
Route
ORAL
Labeler
RARITAN PHARMACEUTICALS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-24
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
100; 2.5 mg/5mL; mg/5mL
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
DRx Choice Childrens Stuffy Nose and Chest Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 04JA59TNSJ
Rxcui1485599

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
68163-748-04DRx Choice Childrens Stuffy Nose and Chest Congestion1 in 1 CARTONSOLUTION13
68163-748-04DRx Choice Childrens Stuffy Nose and Chest Congestion118 mL in 1 BOTTLESOLUTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-748DRX CHOICE CHILDRENS STUFFY NOSE AND CHEST CONGESTION (GUAIFENESIN AND PHENYLEPHRINE HCL) SOLUTION [RARITAN PHARMACEUTICALS]2Current NDC, 2 package rows20241124_7a3bb739-ff50-4d29-b270-d6b084906493.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1485599guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN7a3bb739-ff50-4d29-b270-d6b0849064933
1485599guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD7a3bb739-ff50-4d29-b270-d6b0849064933
1485599guaifenesin 100 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY7a3bb739-ff50-4d29-b270-d6b0849064933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68163-748-04681630748041 BOTTLE in 1 CARTON (68163-748-04) / 118 mL in 1 BOTTLE1 bottle2023-04-24NoNoHistorical