FDA.reportPublic FDA data

Sinus plus Headache

Product NDC
68998-323
11-digit product format
689980323
Labeler code
68998
Product ID
68998-323_2526b65f-4ccf-d493-e063-6294a90ab063
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MARC GLASSMAN, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-15
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 plus 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
68998-323-05Sinus plus Headache2 in 1 CARTONTABLET, COATED24
68998-323-05Sinus plus Headache12 in 1 BLISTER PACKTABLET, COATED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-323SINUS PLUS HEADACHE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MARC GLASSMAN, INC.]4Current NDC, Legacy NDC, 2 package rows20241025_a82401f5-65b1-11e9-e053-2a95a90a499e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNa82401f5-65b1-11e9-e053-2a95a90a499e4
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa82401f5-65b1-11e9-e053-2a95a90a499e4
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYa82401f5-65b1-11e9-e053-2a95a90a499e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68998-323-05689980323052 BLISTER PACK in 1 CARTON (68998-323-05) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-06-150000-00-00NoNoCurrent