FDA.reportPublic FDA data

Giltuss Childrens MultiSymptom Cold and Flu

Product NDC
58552-137
11-digit product format
585520137
Labeler code
58552
Product ID
58552-137_40b8865e-4141-75bb-e063-6394a90aafba
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Giltuss Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-02
Substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength
2; 5; 6.5; 325 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Childrens MultiSymptom Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE6.5 mg/5mL
ACETAMINOPHEN325 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
04JA59TNSJInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2121065Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
852c8cd6-271f-0fa8-e053-2991aa0ab179Available 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
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
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 Children's Multi-Symptom Cold & Flu
2022-01-31Giltuss Children's Multi-Symptom Cold & Flu
2022-01-28Giltuss Children's Multi-Symptom Cold & Flu
2022-01-28Giltuss Children's Multi-Symptom Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-137-04Giltuss Childrens MultiSymptom Cold and Flu1 in 1 CARTONSOLUTION16
58552-137-04Giltuss Childrens MultiSymptom Cold and Flu118 mL in 1 BOTTLESOLUTION1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-137-04ML - Milliliter58552-137b46426ad-5928-4f39-afc4-b968ee09579612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-137GILTUSS CHILDRENS MULTISYMPTOM COLD AND FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [GILTUSS PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20241027_852c8cd6-271f-0fa8-e053-2991aa0ab179.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 22 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Severe Cold Cough and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.a35531d7-1a96-45cb-922f-61db085cde1f2026-06-16WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company5fe9f313-d6e7-41f5-abfc-e4c72b7089612026-06-15WarningsExact identifier
application number: M012
Pain Relief Sinus CongestionACETAMINOPHEN, PHENYLEPHRINE HCLBetter Living Brands, LLC1d3d6397-0d92-4145-9a70-8bcc45bd03222026-06-15WarningsExact identifier
application number: M012
Goodmeds Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f112026-06-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd5d9334d-3db6-4f45-ab84-3e1ec5a752c62026-06-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLGeiss, Destin & Dunn Inc.fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b2026-06-15WarningsExact identifier
application number: M012
equate daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWal-Mart Stores Inc983a4783-d826-41b6-8087-ca66bcd5b6ca2026-06-12WarningsExact identifier
application number: M012
Equate Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc4173ecde-a2d7-4836-a6e9-fef2270d1b4e2026-06-12WarningsExact identifier
application number: M012
PAIN RELIEVER PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)cf370a59-42d5-42fe-882f-09885c55f5702026-06-11WarningsExact identifier
application number: M012
Sudafed Sinus Congestion Plus Cold Severe DayACETAMINOPHEN, PSEUDOEPHEDRINEKenvue Brands LLC537e1a0d-820d-c3f7-e063-6294a90a56ea2026-06-10WarningsExact identifier
application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and NightACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINEKenvue Brands LLC5382dcad-0337-4440-e063-6394a90a706e2026-06-10WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.21cfa71c-7a8f-4100-a42e-9190260653d12026-06-09WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCLWALGREENS47f1d92f-cb4b-1635-e063-6294a90a2c712026-06-09WarningsExact identifier
application number: M012
HALLS HoneyMENTHOLMondelez Global LLC837f5ded-8efb-402b-a1bc-b5c1427556602026-06-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc932b11b1-f4a0-417a-bfa1-05261a1721552026-06-08WarningsExact identifier
application number: M012
NO DRIP NASAL MISTOXYMETAZOLINE HYDROCHLORIDEKroger Company957efbcf-b6d3-4793-bb6e-27e99c9be9052026-06-08WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED493caecb-e687-49ea-b7a1-2a5b9376896d2026-06-08WarningsExact identifier
application number: M012
Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY4ad10fd7-c088-4356-9d34-a95cfe3a41332026-06-08WarningsExact identifier
application number: M012
Theraflu Severe Congestion Relief Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC4ec42064-7390-4137-a93e-57343c3c76a72026-06-08WarningsExact identifier
application number: M012
Theraflu Severe Congestion Relief Cooling Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC90125a19-eed7-4ca4-a6dc-f38026c74d542026-06-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121065acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 6.5 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN852c8cd6-271f-0fa8-e053-2991aa0ab1796
2121065acetaminophen 65 MG/ML / chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 1.3 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD852c8cd6-271f-0fa8-e053-2991aa0ab1796
2121065acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 6.5 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY852c8cd6-271f-0fa8-e053-2991aa0ab1796
2121065APAP 65 MG/ML / Chlorpheniramine Maleate 0.4 MG/ML / Dextromethorphan Hydrobromide 1.3 MG/ML / Phenylephrine Hydrochloride 1 MG/ML Oral SolutionSY852c8cd6-271f-0fa8-e053-2991aa0ab1796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-137-04585520137041 BOTTLE in 1 CARTON (58552-137-04) / 118 mL in 1 BOTTLE1 bottle2018-10-020000-00-00NoNoCurrent