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
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
GUAIFENESIN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
eeca6370-29ea-4540-8139-e8461d58a286	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55505-231-24	SAFETUSSIN Non DrowsyCough plus chest congestion	24 in 1 CARTON	TABLET	24		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55505-231	SAFETUSSIN NON DROWSY COUGH PLUS CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) TABLET [KRAMER LABORATORIES]	2	Current NDC, 1 package rows	20240612_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 76 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Cherry Cough Drops	MENTHOL	Geiss, Destin, Dunn	c72db7f0-9324-8ed2-e053-2995a90a9868	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense Honey Lemon Cough Drops	MENTHOL	Geiss, Destin, Dunn	c72e557f-0211-81b9-e053-2995a90a1437	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense Cherry Benzocaine Lozenges	BENZOCAINE	Geiss, Destin, Dunn	c7404c94-09eb-5cc5-e053-2995a90af021	2025-12-12	Warnings	Exact identifier application number: M012
Good Sense SF Honey Lemon Cough Drops	MENTHOL	Geiss, Destin, Dunn	e11ed21f-6ceb-5908-e053-2995a90aea46	2025-12-12	Warnings	Exact identifier application number: M012
Severe Congestion Relief Maximum Strength Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	59918b8b-5c91-468f-834e-66020dc1ae12	2025-12-12	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	SALADO SALES INC.	8f66f5bc-7c77-420b-9feb-911c980fbfdc	2025-12-12	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	de55a9fd-53a2-4f3e-82b7-cabcbe287d46	2025-12-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	SALADO SALES INC.	cc73b668-cc6a-41d6-800a-4988c59c0449	2025-12-12	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	CHAIN DRUG MARKETING ASSOCIATION INC	75269bcc-3bb2-49a0-8788-6b7da18796d3	2025-12-12	Warnings	Exact identifier application number: M012
Suphedrine PE Sinus plus Allergy	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	affac07f-d645-4999-98ee-7467902f5adc	2025-12-12	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy	ACETAMINOPHEN, PHENYLEPHRINE HCL	WinCo Foods, LLC	f7e925f4-7da6-4157-a97f-e6a3e399911f	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CARDINAL HEALTH	645f8075-e33f-4e1a-9249-7368261cdcb9	2025-12-11	Warnings	Exact identifier application number: M012
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	8fd0071b-c6ca-49e6-b159-45dead71b664	2025-12-11	Warnings	Exact identifier application number: M012
Geri-Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	098582dc-3e12-782f-e063-6394a90aa1a1	2025-12-11	Warnings	Exact identifier application number: M012
GUAIASORB DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	09866b9c-aa32-45eb-e063-6394a90a4903	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	d6947661-a6dd-4bc4-a0ca-932db1840f58	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	2e751d67-51b4-4b74-a9e8-7f3bc5636984	2025-12-11	Warnings	Exact identifier application number: M012
Pressure and Pain Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	232acb86-7383-4992-b333-1e47bf7c06ad	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	72847721-9f59-4af1-8f20-dc8449742918	2025-12-11	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	f6401317-0295-14b3-e053-2a95a90acbb4	2025-12-11	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2173726	dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Tablet	PSN	eeca6370-29ea-4540-8139-e8461d58a286	3
2173726	dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Tablet	SCD	eeca6370-29ea-4540-8139-e8461d58a286	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55505-231-24	55505023124	24 TABLET in 1 CARTON (55505-231-24)	24 tablet	2024-05-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SAFETUSSIN Non-Drowsy Cough + Chest Congestion	KRAMER LABORATORIES \| RARITAN PHARMACEUTICALS INCORPORATED	2025-12-23	HUMAN OTC DRUG LABEL	3