FDA.reportPublic FDA data

Giltuss Sinus and Chest Congestion

Product NDC
58552-332
11-digit product format
585520332
Labeler code
58552
Product ID
58552-332_5746ab21-fd63-7ac4-e063-6394a90aa199
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
Marketing end
2027-02-28
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
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Giltuss Sinus and Chest Congestion

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1946782Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8591003c-c2f2-df65-e053-2a91aa0a42fbAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 98 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporation0ea61a4c-690a-4349-9952-cc17fb1f06712025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporation892092cc-5a1c-4309-baf9-a040888d35772025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporation773f4ad2-6c91-431f-ad3d-c0e53e7ca9182025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporation13c7d3b1-12ac-4931-877c-728d3d89942c2025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporationd0c878f0-a737-4583-9847-834af70e7d6f2025-10-08WarningsExact identifier
application number: M012
Cough Drops Freegells Strawberry 30ctMENTHOLR.L. ALBERT & SON, INCdc077c36-c403-4b83-894a-e9922e9288412025-10-08WarningsExact identifier
application number: M012
Cough Drops Freegells Strawberry 30ctMENTHOLRL Albert & Son Inc.2ea760f3-df50-4c46-a43d-d5ed07f421a52025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Honey Lemon 200ctMENTHOLRL Albert & Son Inc.3ac08274-08d9-4dab-b09a-6e297948a25a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Honey Lemon 30ctMENTHOLRL Albert & Son Inc.8114e1a2-728d-4489-a494-f28a5e7d9bb32025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 30ctMENTHOLRL Albert & Son Inc.0c2e594a-cdf8-4595-bda6-0ebc19ac38502025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 200ctMENTHOLR.L. ALBERT & SON, INCf62b7f75-3275-46c9-880c-64148d0dce592025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 80ctMENTHOLR.L. ALBERT & SON, INC15917bfb-f660-4a12-bdcc-5b4a96e0e1d02025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 30ctMENTHOLRL Albert & Son Inc.92c54c53-c8bb-4576-abae-715a2f3878bf2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 80ctMENTHOLRL Albert & Son Inc.c96cc162-5908-4990-9dc1-3ce9128442742025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 30ctMENTHOLR.L. ALBERT & SON, INCbac77712-6197-4b30-a5f8-9b99eb9d7b5a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLR.L. ALBERT & SON, INC6842d766-ade6-40b2-831b-f4feac25c6db2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLRL Albert & Son Inc.9f324ca1-0e2a-47e3-997e-2aaa68a857512025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INC2063a013-aa0b-465d-b04f-cfe2e70d749f2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 200ctMENTHOLR.L. ALBERT & SON, INCcd81488c-74d8-48d9-9c73-ff662a5cd4cd2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 80ctMENTHOLR.L. ALBERT & SON, INC61deea94-d0a9-4563-926b-53f255a7c4252025-10-08WarningsExact identifier
application number: M012

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 pack2021-04-012027-02-28NoNoCurrent