FDA.reportPublic FDA data

SINUS AND HEADACHE

Product NDC
53943-323
11-digit product format
539430323
Labeler code
53943
Product ID
53943-323_24adcdf2-1434-b681-e063-6394a90a9b02
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-01
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
SINUS AND HEADACHE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 04JA59TNSJ
Rxcui1046378

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
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-323-05SINUS AND HEADACHE12 in 1 BLISTER PACKTABLET, COATED124
53943-323-05SINUS AND HEADACHE2 in 1 CARTONTABLET, COATED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-323SINUS AND HEADACHE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [DISCOUNT DRUG MART]4Current NDC, Legacy NDC, 2 package rows20241019_a7e99dad-5916-6a90-e053-2a95a90a8803.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNa7e99dad-5916-6a90-e053-2a95a90a88034
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa7e99dad-5916-6a90-e053-2a95a90a88034
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYa7e99dad-5916-6a90-e053-2a95a90a88034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-323-05539430323052 BLISTER PACK in 1 CARTON (53943-323-05) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-09-010000-00-00NoNoCurrent