FDA.reportPublic FDA data

Giltuss D

Product NDC
65852-010
11-digit product format
658520010
Labeler code
65852
Product ID
65852-010_3f17eefb-b626-b0f2-e063-6294a90afd4d
Type
HUMAN OTC DRUG
Nonproprietary name
Giltuss D
Dosage form
SYRUP
Route
ORAL
Labeler
Dextrum Laboratories Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-11
Substance
PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength
10; 3.5 mg/10mL; mg/10mL
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

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 D
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/10mL
CHLORPHENIRAMINE MALEATE3.5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2724415Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f17eefb-b625-b0f2-e063-6294a90afd4dAvailable 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
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
65852-010-04Giltuss D1 in 1 CARTONSYRUP11
65852-010-04Giltuss D118 mL in 1 BOTTLE, PLASTICSYRUP1181

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 19 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC2ee6df99-727a-34c6-e063-6294a90a6bbc2026-07-06WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC28ec213e-fabb-28ec-e063-6394a90ad1022026-07-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRSelect Consumer Group55fc7d6f-cc44-b4c0-e063-6294a90ae4fc2026-07-06WarningsExact identifier
application number: M012
Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLDOLGENCORP, LLCf2eacb1b-8b29-41ec-828a-c1f902ac09342026-07-06WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d10292-e673-9896-e063-6294a90a56742026-07-04WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group55bddbea-5ad9-6a18-e063-6394a90a461d2026-07-03WarningsExact identifier
application number: M012
CONTAC COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEVESPYR BRANDS LLCf72d510b-e370-4137-8d4f-d9afd5d19a192026-07-03WarningsExact identifier
application number: M012
Nite time Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf8f84be1-e3b1-4e93-8e1c-ee93e1f4af132026-07-02WarningsExact identifier
application number: M012
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.9d355bf8-6398-4f3a-902a-c41cf5840c152026-07-02WarningsExact identifier
application number: M012
TUSSIN CF SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC01d6c897-619d-4a6d-8950-4d6d32346b9b2026-07-01WarningsExact identifier
application number: M012
NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.161c34b4-3cd2-40b4-b13e-ad980ad4249c2026-07-01WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)437cd589-f5da-4390-b178-609d4537eaab2026-07-01WarningsExact identifier
application number: M012
Cold and Flu Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL.N.K. International, Inc.9167a80e-fcf0-4b64-97e6-8a8ac566f1342026-06-29WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART55653790-9400-e63b-e063-6394a90ae5f72026-06-29WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART55656a74-9721-62cf-e063-6394a90a7eb72026-06-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC5565f02b-ce38-339f-e063-6294a90a671c2026-06-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.b3be2068-39e8-45f8-950e-afaee2c2520f2026-06-29WarningsExact identifier
application number: M012
NIGHTTIME COUGH DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED646f65f4-b9e4-4291-aadc-d2070848d35c2026-06-29WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLC259b6f12-50c0-4e7a-9a44-bdf7e9a20a562026-06-29WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC31755678-825c-b84a-e063-6294a90a5a832026-06-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2724415chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG in 10 mL Oral SolutionPSN3f17eefb-b625-b0f2-e063-6294a90afd4d1
2724415chlorpheniramine maleate 0.35 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD3f17eefb-b625-b0f2-e063-6294a90afd4d1
2724415chlorpheniramine maleate 1.75 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY3f17eefb-b625-b0f2-e063-6294a90afd4d1
2724415chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG per 10 ML Oral SolutionSY3f17eefb-b625-b0f2-e063-6294a90afd4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65852-010-04658520010041 BOTTLE, PLASTIC in 1 CARTON (65852-010-04) / 118 mL in 1 BOTTLE, PLASTIC2024-04-11NoNoCurrent