Giltuss Sinus and Chest Congestion

Product NDC
58552-332
11-digit product format
585520332
Labeler code
58552
Product ID
58552-332_40b98fe6-b671-7255-e063-6294a90a0d73
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-01
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
388; 10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Giltuss Sinus and Chest Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN388 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 04JA59TNSJ
Rxcui1946782

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-332-20Giltuss Sinus and Chest Congestion2 in 1 CARTONTABLET28
58552-332-20Giltuss Sinus and Chest Congestion10 in 1 BLISTER PACKTABLET108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-332-20EA - Each58552-332dde47d9b-7a85-421a-a50a-700684e4057a12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-332GILTUSS SINUS AND CHEST CONGESTION (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP]7Current NDC, Legacy NDC, 2 package rows20250315_8591003c-c2f2-df65-e053-2a91aa0a42fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1946782guaiFENesin 388 MG / phenylephrine HCl 10 MG Oral TabletPSN8591003c-c2f2-df65-e053-2a91aa0a42fb8
1946782guaifenesin 388 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD8591003c-c2f2-df65-e053-2a91aa0a42fb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-332-20585520332202 BLISTER PACK in 1 CARTON (58552-332-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2021-04-010000-00-00NoNoCurrent