FDA.reportPublic FDA data

Giltuss Cough and Cold

Product NDC
58552-331
11-digit product format
585520331
Labeler code
58552
Product ID
58552-331_5746a790-450c-79d7-e063-6394a90a7077
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, 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
2027-01-30
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
388; 28; 10 mg/1; mg/1; mg/1
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
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN388 mg/1
DEXTROMETHORPHAN HYDROBROMIDE28 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal 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
2167784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8590fcc9-c0dd-f43b-e053-2991aa0a692eAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-331-20Giltuss Cough and Cold2 in 1 CARTONTABLET27
58552-331-20Giltuss Cough and Cold10 in 1 BLISTER PACKTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-331-20EA - Each58552-331d108afdb-aecd-4da1-97e1-bd810c74905c12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-331GILTUSS COUGH AND COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 2 package rows20250315_8590fcc9-c0dd-f43b-e053-2991aa0a692e.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 16 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLWinCo Foods, LLC2cbf27b6-217c-46d8-89c9-e46f3668f0022026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)d86d53cd-75ce-4c40-83cb-ada9b77a76f62026-07-17WarningsExact identifier
application number: M012
LEADER Multi Symptom Flu Relief Daytime Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER2212cf9e-6944-4922-b5b5-1373cf10b2e12026-07-16WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATECVS PHARMACY06756130-1608-4ae6-9772-95a4549853a12026-07-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLOld East Main Co.7855033e-6a12-4cd8-b0a2-c5d69018d1172026-07-16Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline Hydrochloride 12-HourOXYMETAZOLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.34a79f8b-32b7-48db-a895-c942cc7952922026-07-16WarningsExact identifier
application number: M012
LoHist DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.93c9ad4f-3376-48c2-8276-0375663acd012026-07-16WarningsExact identifier
application number: M012
SanatosMENTHOLPharmadel LLC522e1e7f-98ed-c475-e063-6294a90a622c2026-07-16WarningsExact identifier
application number: M012
LEADER MS Flu Relief NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d2026-07-16WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC1bf4cd96-5800-434d-a0dc-e84c759ebb332026-07-16WarningsExact identifier
application number: M012
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINWalgreens2ace231a-94c4-479d-bb26-454bd07b207b2026-07-16WarningsExact identifier
application number: M012
LEADER No DripALLERGY SINUS NASAL MISTCARDINAL HEALTH 110, LLC. DBA LEADERe7b2c1c1-6250-4af3-b131-22aced2b23d52026-07-16WarningsExact identifier
application number: M012
Mucus Relief DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergen639a59b7-ccff-485e-a232-38b6808272292026-07-16WarningsExact identifier
application number: M012
Equate Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.30470a01-4d42-44c6-a017-d68bb74cdef72026-07-15WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93fe6d-ee21-e323-e063-6394a90a61bf2026-07-15WarningsExact identifier
application number: M012
Pentrexcilina DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93c815-63c7-bfe0-e063-6394a90ab4a52026-07-15WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp5fa848ef-35ee-4e05-8ff2-781d034cf6ac2026-07-14WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leader0fad61d8-4393-47ec-9ff6-7df5be761f5b2026-07-14WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLRite Aid Corporation211c4273-3b2c-4169-b9c6-7a87903e77cd2026-07-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2167784dextromethorphan HBr 28 MG / guaiFENesin 388 MG / phenylephrine HCl 10 MG Oral TabletPSN8590fcc9-c0dd-f43b-e053-2991aa0a692e7
2167784dextromethorphan hydrobromide 28 MG / guaifenesin 388 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD8590fcc9-c0dd-f43b-e053-2991aa0a692e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-331-20585520331202 BLISTER PACK in 1 CARTON (58552-331-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2021-04-012027-01-30NoNoCurrent