FDA.reportPublic FDA data

Allergy plus Sinus Headache

Product NDC
68210-4190
11-digit product format
682104190
Labeler code
68210
Product ID
68210-4190_ee8e73a8-23d2-ab48-e053-2a95a90a24eb
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-11-11
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 productproduct68210-4190IInactivated by FDA2026-10-12
excluded packagepackage68210-419068210-4190-1IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4190-1Allergy plus Sinus Headache1 in 1 CARTONTABLET, COATED15
68210-4190-1Allergy plus Sinus Headache12 in 1 BOTTLETABLET, COATED125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4190ALLERGY PLUS SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241211_7364ffe1-26bf-4d05-94d0-ef946287def9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233575acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletPSN7364ffe1-26bf-4d05-94d0-ef946287def95
1233575acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD7364ffe1-26bf-4d05-94d0-ef946287def95
1233575acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletSY7364ffe1-26bf-4d05-94d0-ef946287def95
1233575APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY7364ffe1-26bf-4d05-94d0-ef946287def95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4190-1682104190011 BOTTLE in 1 CARTON (68210-4190-1) > 12 TABLET, COATED in 1 BOTTLE1 bottle2021-11-110000-00-00NoNoCurrent