Sun Mark Tussin DM

Product NDC: 49348-017
11-digit product format: 493480017
Labeler code: 49348
Product ID: 49348-017_2428f13d-ee43-4c43-b982-88bb7e393cf3
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan Hydrobromide, Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2003-06-27
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20 mg/10mL; mg/10mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49348-017		D	Discontinued by firm	2026-08-11
excluded package	package	49348-017	49348-017-34	D	Discontinued by firm	2026-08-11
excluded package	package	49348-017	49348-017-37	D	Discontinued by firm	2026-08-11
excluded package	package	49348-017	49348-017-39	D	Discontinued by firm	2026-08-11

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-017-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-017-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-017-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-017-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-017-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-017-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-017-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-017-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-017-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-017-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-017-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-017-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-017-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-017-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-017-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-017-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-017-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-017-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-017-39	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-017-37	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-017-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-017-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-017-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-017-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-017-39	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-017-37	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-017-34	`0efc9e666f02…`	`f202fb6c5f17…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-017-34	ML - Milliliter	49348-017	dc120335-7736-48e7-aa3c-8654f547d9db	1	2012-07-24
49348-017-37	ML - Milliliter	49348-017	9578848d-f65a-4c98-b197-e0583922ac72	1	2012-07-24
49348-017-39	ML - Milliliter	49348-017	cb098ba1-c27c-4eac-bf4a-0508ad76139b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]	4

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
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	e6d57e60-39f3-461a-b1d7-81f62ef57837	3
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	e6d57e60-39f3-461a-b1d7-81f62ef57837	3
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	e6d57e60-39f3-461a-b1d7-81f62ef57837	3
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	e6d57e60-39f3-461a-b1d7-81f62ef57837	3
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	e6d57e60-39f3-461a-b1d7-81f62ef57837	3
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	d1783226-15f3-29c8-e053-2a95a90ab774	2
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	d1783226-15f3-29c8-e053-2a95a90ab774	2
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	d1783226-15f3-29c8-e053-2a95a90ab774	2
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	d1783226-15f3-29c8-e053-2a95a90ab774	2
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	d1783226-15f3-29c8-e053-2a95a90ab774	2
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	3521aaab-a291-41db-9ee3-107e163e9a88	1
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	3521aaab-a291-41db-9ee3-107e163e9a88	1
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	3521aaab-a291-41db-9ee3-107e163e9a88	1
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	3521aaab-a291-41db-9ee3-107e163e9a88	1
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	3521aaab-a291-41db-9ee3-107e163e9a88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-017-34	49348001734	1 BOTTLE in 1 CARTON (49348-017-34) > 118 mL in 1 BOTTLE	1 bottle	2003-07-03	0000-00-00	No	No	Current
49348-017-37	49348001737	1 BOTTLE in 1 CARTON (49348-017-37) > 236 mL in 1 BOTTLE	1 bottle	2003-06-27	0000-00-00	No	No	Current
49348-017-39	49348001739	1 BOTTLE in 1 CARTON (49348-017-39) > 354 mL in 1 BOTTLE	1 bottle	2003-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Tussin DM Drug Facts	NuCare Pharmaceuticals,Inc, \| NuCare Pharmaceuticals,Inc.	2023-06-07	HUMAN OTC DRUG LABEL	2
McKesson Tussin DM Drug Facts	A-S Medication Solutions	2021-04-16	HUMAN OTC DRUG LABEL	3
McKesson Tussin DM Drug Facts	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN OTC DRUG LABEL	2
McKesson Tussin DM Drug Facts	Strategic Sourcing Services LLC	2020-01-31	HUMAN OTC DRUG LABEL	6
Sunmark Tussin DM Cough and Chest Congestion	Central Texas Community Health Centers	2017-11-17	HUMAN OTC DRUG LABEL	1