FDA.reportPublic FDA data

Tussin CF Multi-Symptom Cold

Product NDC
53942-504
11-digit product format
539420504
Labeler code
53942
Product ID
53942-504_dd517595-1514-4f3e-8d62-81c3ad57270c
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
DeMoulas Market Basket
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-20
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 100; 5 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
2027-12-31
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
Tussin CF Multi-Symptom Cold
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 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
1044949Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c19b9997-4037-48f3-b905-86da421a292dAvailable 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
53942-504-26Tussin CF Multi-Symptom Cold237 mL in 1 BOTTLELIQUID2373

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
SORBITOLINACTIVE INGREDIENT506T60A25RTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-504TUSSIN CF MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]3Current NDC, Legacy NDC, 1 package rows20231230_c19b9997-4037-48f3-b905-86da421a292d.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
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSNc19b9997-4037-48f3-b905-86da421a292d3
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDc19b9997-4037-48f3-b905-86da421a292d3
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYc19b9997-4037-48f3-b905-86da421a292d3
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYc19b9997-4037-48f3-b905-86da421a292d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-504-2653942050426237 mL in 1 BOTTLE (53942-504-26) 237 ml2012-09-200000-00-00NoNoCurrent