Giltuss Allergy Plus

Product NDC
58552-334
11-digit product format
585520334
Labeler code
58552
Product ID
58552-334_40b9e4b7-e384-5aef-e063-6294a90a338d
Type
HUMAN OTC DRUG
Nonproprietary name
Chlophedianol HCl, Chlorpheniramine maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-01
Substance
CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
24; 3.5; 10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Giltuss Allergy Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE24 mg/1
CHLORPHENIRAMINE MALEATE3.5 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii69QQ58998Y, V1Q0O9OJ9Z, 04JA59TNSJ
Rxcui1424872

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-334-20Giltuss Allergy Plus10 in 1 BOXTABLET107
58552-334-20Giltuss Allergy Plus2 in 1 POUCHTABLET27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-334-20EA - Each58552-3340bd033eb-0685-492e-bc5d-585aed9a613c12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-334GILTUSS ALLERGY PLUS (CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 2 package rows20250315_85a0dc7f-ffb5-7d52-e053-2991aa0a602a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424872chlophedianol HCl 24 MG / chlorpheniramine maleate 3.5 MG / phenylephrine HCl 10 MG Oral TabletPSN85a0dc7f-ffb5-7d52-e053-2991aa0a602a7
1424872chlophedianol hydrochloride 24 MG / chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD85a0dc7f-ffb5-7d52-e053-2991aa0a602a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-334-205855203342010 POUCH in 1 BOX (58552-334-20) / 2 TABLET in 1 POUCH10 pouch2021-04-010000-00-00YesNoCurrent