FDA.reportPublic FDA data

head congestion plus mucus PE

Product NDC
41250-573
11-digit product format
412500573
Labeler code
41250
Product ID
41250-573_e95c4ccd-e0a7-9bc5-e053-2a95a90ad053
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MEIJER DISTRIBUTION INC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-09-23
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41250-573DDiscontinued by firm2026-10-05
excluded packagepackage41250-57341250-573-02DDiscontinued 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
41250-573-02head congestion plus mucus PE2 in 1 CARTONTABLET, COATED23
41250-573-02head congestion plus mucus PE12 in 1 BLISTER PACKTABLET, COATED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-573HEAD CONGESTION PLUS MUCUS PE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER DISTRIBUTION INC]3Legacy NDC, 2 package rows20241013_e83ed5c6-6ac6-82b1-e053-2a95a90a2f9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNe83ed5c6-6ac6-82b1-e053-2a95a90a2f9d3
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe83ed5c6-6ac6-82b1-e053-2a95a90a2f9d3
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYe83ed5c6-6ac6-82b1-e053-2a95a90a2f9d3
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYe83ed5c6-6ac6-82b1-e053-2a95a90a2f9d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-573-02412500573022 BLISTER PACK in 1 CARTON (41250-573-02) > 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2022-09-230000-00-00NoNoCurrent