FDA.reportPublic FDA data

Cold and Head Congestion Severe

Product NDC
68016-717
Requested package NDC
68016-717-24
11-digit product format
680160717
Labeler code
68016
Product ID
68016-717_af0ca8ae-19a4-bd25-e053-2a95a90a6cc6
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG CONSORTIUM
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68016-71768016-717-24DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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]3Legacy 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 pack2015-06-010000-00-00NoNoCurrent