FDA.reportPublic FDA data

Giltuss Cough and Cold

Product NDC
58552-130
11-digit product format
585520130
Labeler code
58552
Product ID
58552-130_40b83027-94f0-8f48-e063-6294a90ad555
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-02
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
15; 300; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 Cough and Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL
GUAIFENESIN300 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
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
1251031Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8503c956-42a5-7684-e053-2991aa0adb27Available 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-01-31Giltuss Cough & Cold
2022-01-31Giltuss Cough & Cold
2022-01-28Giltuss Cough & Cold
2022-01-28Giltuss Cough & Cold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-130-04Giltuss Cough and Cold118 mL in 1 BOTTLESOLUTION1186
58552-130-04Giltuss Cough and Cold1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-130-04ML - Milliliter58552-130f85e8994-a7d1-41e8-a54b-06be809ebd1212019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-130GILTUSS COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [GIL PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20241027_8503c956-42a5-7684-e053-2991aa0adb27.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 55 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S2RACEPINEPHRINE HYDROCHLORIDENephron Pharmaceuticals Corporationdd1b35c7-b23b-4b95-8162-df3d263fe32e2026-01-26WarningsExact identifier
application number: M012
SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d97c634-0975-42d5-8ade-2ed2018cfe9d2026-01-26WarningsExact identifier
application number: M012
GOOD SENSE NIGHT TIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEL. Perrigo Companycd68289b-3850-40c6-9439-aae0e2d7637d2026-01-26WarningsExact identifier
application number: M012
Seacall Nasal Spray.NASAL SPRAYGuangdong Quadrant Ecological Technology Co., Ltd.1f12618b-7461-fb47-e063-6294a90af7532026-01-23WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf7d210-102c-4053-81f6-67116de6cf7b2026-01-23WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergen44f9255b-0bf9-4573-ac9c-410acb515bc22026-01-23WarningsExact identifier
application number: M012
Daytime cold and flu non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMeijer Distribution Inc29caa3a7-7fe6-4134-a9b0-49bdb9280ca72026-01-23WarningsExact identifier
application number: M012
good neighbor pharmacy night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergene2b5c27e-ca5f-4503-a3ce-c86e1d8070a72026-01-23WarningsExact identifier
application number: M012
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATERaritan Pharmaceuticals Inc.f466fc0e-3384-4884-832e-99bf1fdcf8992026-01-21WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR GUAIFENESINStrategic Sourcing Services LLC84750bfb-9e94-40a3-b731-21799f5e4fd12026-01-20WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRAmerisource Bergen0b58990f-2246-408e-9365-51f56bb6766c2026-01-20WarningsExact identifier
application number: M012
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATECARDINAL HEALTH 110, LLC. DBA LEADER 70000a8460fc9-2d08-4e5f-8dd3-5135ecda59232026-01-20WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services Inc0a651316-623e-41eb-ab3a-641f5d8074252026-01-20WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and FluWALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWalgreens579c47c8-6366-4785-9680-d3986ce9641d2026-01-19WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and ColdWALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLDWalgreensdd61c9d3-0b70-450e-9525-282710b383cc2026-01-19WarningsExact identifier
application number: M012
Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC48bf7422-38ef-d4b4-e063-6294a90aa3ab2026-01-19WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensfc670515-a820-4ea7-8786-8ae710798b312026-01-19WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWALGREENS9dece7b1-00b1-2499-e053-2a95a90a0be32026-01-19WarningsExact identifier
application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreens2dba2bec-e0e3-4910-89c5-ebc093e05bec2026-01-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251031dextromethorphan HBr 15 MG / guaiFENesin 300 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN8503c956-42a5-7684-e053-2991aa0adb276
1251031dextromethorphan hydrobromide 3 MG/ML / guaifenesin 60 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD8503c956-42a5-7684-e053-2991aa0adb276
1251031dextromethorphan HBr 15 MG / guaifenesin 300 MG / phenylephrine HCl 10 MG per 5 ML Oral SolutionSY8503c956-42a5-7684-e053-2991aa0adb276

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-130-04585520130041 BOTTLE in 1 CARTON (58552-130-04) / 118 mL in 1 BOTTLE1 bottle2018-10-020000-00-00NoNoCurrent