FDA.reportPublic FDA data

SAFETUSSIN Non Drowsy

Product NDC
55505-231
11-digit product format
555050231
Labeler code
55505
Product ID
55505-231_4c618596-e3fe-4557-8ccb-0867ebb871c9
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, and Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
KRAMER LABORATORIES
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-17
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 200 mg/1; mg/1
Pharmacologic classes
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]
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
SAFETUSSIN Non Drowsy
Brand name suffix
Cough plus chest congestion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2173726Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eeca6370-29ea-4540-8139-e8461d58a286Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-231-24SAFETUSSIN Non DrowsyCough plus chest congestion24 in 1 CARTONTABLET243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-231SAFETUSSIN NON DROWSY COUGH PLUS CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) TABLET [KRAMER LABORATORIES]2Current NDC, 1 package rows20240612_eeca6370-29ea-4540-8139-e8461d58a286.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 138 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc81f12484-ddf7-49c6-b530-3a81d62ab40d2024-11-10WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRetail Business Services, LLC230fa1ea-ae7c-425e-8447-79a90c96ae9e2024-11-10WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Companycb8a1d81-b1a3-4217-b157-9e5d398f202d2024-11-09WarningsExact identifier
application number: M012
PhysiciansCare Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEAcme United Corporation5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2024-11-09WarningsExact identifier
application number: M012
DurafluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.55fffc1d-8449-4c28-a391-c6f60dd856222024-11-09WarningsExact identifier
application number: M012
Poly-Vent IRGUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.ce0d8c45-446a-4df4-a36b-5000ba69d30d2024-11-09WarningsExact identifier
application number: M012
basic care tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC306d5914-03ed-410a-9345-c54ba604e9912024-11-09WarningsExact identifier
application number: M012
care one nasal originalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companya0c35e06-c9e9-438e-8224-d4760b6e2aff2024-11-09WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company34174507-cf2e-4ed4-85ec-f915d4b910df2024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl ChewablesDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCb08f71d8-a06c-41ba-8ed1-fbc41dbc19192024-11-08WarningsExact identifier
application number: M012
SUDAFED PE SINUS CONGESTIONDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCa38fdfb8-db89-487f-9b68-aa9152b91f5f2024-11-08WarningsExact identifier
application number: M012
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC2884d2dc-2d4a-4ca6-ab73-688a80b428eb2024-11-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/NightACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATEKenvue Brands LLC712ba011-79aa-469b-9f0f-04a0b4b705bd2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8538c291-9ce9-4866-b268-f4cbdb52f5bd2024-11-08WarningsExact identifier
application number: M012
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsExact identifier
application number: M012
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC60183922-bfd3-4377-884a-51b2f0a4c93a2024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus MucusACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCf0739186-41b9-4761-adf7-08101b30a18e2024-11-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2173726dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral TabletPSNeeca6370-29ea-4540-8139-e8461d58a2863
2173726dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral TabletSCDeeca6370-29ea-4540-8139-e8461d58a2863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55505-231-245550502312424 TABLET in 1 CARTON (55505-231-24) 24 tablet2024-05-17NoNoCurrent