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 21 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)bfec14d5-d9ce-4b9c-a803-3d01cb00b56c2026-06-22WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
application number: M012
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
application number: M012
NO DRIP NASALPHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7a866cdf-1c0c-403a-afc8-0e99e0ce81aa2026-06-22WarningsExact identifier
application number: M012
Maximum Strength Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBRKROGER COMPANY30d4c4b9-0f5f-0279-e063-6394a90af1b52026-06-19WarningsExact identifier
application number: M012
GoodMeds Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.6a8a961c-d2d2-428d-8af7-8527aae25c8a2026-06-19WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI490766e7-1781-4b2b-a8f4-d4efb9fff5602026-06-19WarningsExact identifier
application number: M012
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWALMART INC.30f6d588-ad80-4348-a45f-77337e067bca2026-06-19WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINCardinal Health 107, LLC888b6a2e-6631-4585-a7fe-eb122eb51b232026-06-18WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi Symptom DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5487b2e1-b0e5-0236-e063-6394a90a3a8b2026-06-18WarningsExact identifier
application number: M012
Vaporizing Colds RubMENTHOLDelon Laboratories (1990) Ltd3ed8bc0c-c229-450b-a491-06b578c1b8ee2026-06-18WarningsExact identifier
application number: M012
Allergy ChildrensDIPHENHYDRAMINE HCLDOLGENCORP, LLC218c447e-9ddd-428a-9b33-0acec35e0d1b2026-06-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.a9d5f9f4-ddec-4ad6-ad06-4a612008bb682026-06-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Companye49d2a0f-6588-439b-8a46-c073e0bc4f9a2026-06-17WarningsExact identifier
application number: M012
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafewayac0380ad-c9fa-4bda-ab84-c2e6aa672bdf2026-06-17WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1a21cbb2-1ba5-414f-a31f-42b7a7bddae52026-06-16WarningsExact identifier
application number: M012
Tussin DM RegularDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.5460c809-71c8-3ad6-e063-6294a90a4e4f2026-06-16WarningsExact identifier
application number: M012
Equate Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.4b111580-cd20-43ec-9ff4-4b9f74f7d2e82026-06-16WarningsExact identifier
application number: M012
Sinus CongestionPHENYLEPHRINE HCLChain Drug Marketing Association, Inc.43a77f89-e66a-4db6-8067-f614c0e207df2026-06-16WarningsExact identifier
application number: M012
severe sinus congestion relief Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation51175d3e-e1c3-4e4d-ad32-61600e87568c2026-06-16WarningsExact 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