Tussin CF

Product NDC
53943-504
11-digit product format
539430504
Labeler code
53943
Product ID
53943-504_6af7fb23-9adb-4225-9773-c49ab6dd60d6
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Discount Drug Mart
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-19
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53943-504-26e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53943-504-269bebd1f3094a…5416666fcb17…

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
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
f8e7a08e-7422-4a1b-bfec-93e0b50d10cdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-504-262020-12-31C16284748780-19d75b9d0-48a3-f424-e053-dadaa90a57cef8e7a08e-7422-4a1b-bfec-93e0b50d10cd
53943-504-262020-01-31C16284748780-19d75b9d0-48a3-f424-e053-dadaa90a57cef8e7a08e-7422-4a1b-bfec-93e0b50d10cd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-504-26Tussin CF237 mL in 1 BOTTLELIQUID2376

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-504TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DISCOUNT DRUG MART]5Current NDC, Legacy NDC, 1 package rows20241222_f8e7a08e-7422-4a1b-bfec-93e0b50d10cd.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 28 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Mucus Cough and Congestion ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8b5d391b-6c23-44c3-81d0-c08822bf6d012026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom ColdACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCe048cd53-a3cd-484f-a972-4cb49791dba32026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens CoughDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCb8132c81-5291-431a-ad3a-ec8a3eb21c192026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7354f57c-0ecf-481f-9482-0040c90c43502026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC5bda415d-739f-4ca5-b5b2-07c14a81863b2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8f3eb5c5-832e-4806-b3da-ef112cf55dcf2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDEReckitt Benckiser LLCe3aea6df-37a4-43c5-a192-a902cbff3f922026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd9e5a8d7-814c-4ab1-bb05-e4cb9155978e2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple PackACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINReckitt Benckiser LLCc7ab5201-8550-4bf4-957c-c8f049aeaa4a2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC84e7be8f-2785-45ef-9c44-de05394fcd992026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC771d7fd8-184f-48a3-90ed-e8f00159d97e2026-05-18WarningsExact identifier
application number: M012
MUCINEX Childrens Stuffy NoseOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLCde1c0abd-1644-4351-8106-e9df6ca5c1422026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Fever Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1538a75d-582a-9501-e063-6394a90a6c552026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC19105007-0193-0764-e063-6294a90a01a42026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and FluDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC34fd2458-9acd-cdf7-e063-6394a90a3d0a2026-05-18WarningsExact identifier
application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3a24b06c-00a6-c2ef-e063-6294a90a4d722026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC14be3ab0-d6ae-e342-e063-6294a90ab8512026-05-18WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLBryant Ranch Prepack20f00537-2c8a-45d1-8e5f-ec276d0a47b62026-05-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.38df2308-f6f9-4476-ad34-4b5bc5f9fdf22026-05-18WarningsExact identifier
application number: M012
Allergy Plus Headache ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.88e3b969-79d0-4e64-95c0-c5cfd41e365f2026-05-18WarningsExact 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 SolutionPSNf8e7a08e-7422-4a1b-bfec-93e0b50d10cd6
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDf8e7a08e-7422-4a1b-bfec-93e0b50d10cd6
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYf8e7a08e-7422-4a1b-bfec-93e0b50d10cd6
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYf8e7a08e-7422-4a1b-bfec-93e0b50d10cd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-504-2653943050426237 mL in 1 BOTTLE (53943-504-26) 237 ml2014-11-190000-00-00NoNoCurrent