FDA.reportPublic FDA data

Cold and Head Congestion Severe

Product NDC
68016-717
11-digit product format
680160717
Labeler code
68016
Product ID
68016-717_2434193f-6ba3-923d-e063-6394a90aec0c
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG CONSORTIUM
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-01
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold and Head Congestion Severe

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-717-24Cold and Head Congestion Severe2 in 1 CARTONTABLET, COATED23
68016-717-24Cold and Head Congestion Severe12 in 1 BLISTER PACKTABLET, COATED123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-717-24EA - Each68016-7172c0d3ad3-88bc-4180-bc50-32ffcf6b834912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-717COLD AND HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG CONSORTIUM]3Current NDC, Legacy NDC, 2 package rows20241013_f3163a9f-e916-4b61-80ab-ed5f1e7579f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNf3163a9f-e916-4b61-80ab-ed5f1e7579f83
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf3163a9f-e916-4b61-80ab-ed5f1e7579f83
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf3163a9f-e916-4b61-80ab-ed5f1e7579f83
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf3163a9f-e916-4b61-80ab-ed5f1e7579f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-717-24680160717242 BLISTER PACK in 1 CARTON (68016-717-24) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2015-06-012026-07-31NoNoCurrent