FDA.reportPublic FDA data

sunmark tussin

Product NDC
49348-135
Requested package NDC
49348-135-34
11-digit product format
493480135
Labeler code
49348
Product ID
49348-135_ed2b44d3-8568-46e6-a618-63e6ec9eaab4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-09-17
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
200 mg/10mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-13549348-135-34DDiscontinued by firm2026-10-05

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-135-34ML - Milliliter49348-1351918039d-31fd-4565-a59d-248561298c0e12015-05-05
49348-135-37ML - Milliliter49348-135fb803d6b-5607-4743-8d0c-ad1777ddaeba12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
GUAIFENESINACTIVE MOIETY495W7451VQSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
MALTOLINACTIVE INGREDIENT3A9RD92BS4SUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK TUSSIN (GUAIFENESIN) SOLUTION [MCKESSON]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN7b1492ef-c8ab-4776-97b1-5982d2ea69a01
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 20 MG/ML Oral SolutionSCD7b1492ef-c8ab-4776-97b1-5982d2ea69a01
310604guaifenesin 20 MG/ML Oral SolutionSCDdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 100 MG per 5 ML Oral SolutionSY7b1492ef-c8ab-4776-97b1-5982d2ea69a01
310604guaifenesin 100 MG per 5 ML Oral SolutionSYdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 100 MG per 5 ML Oral SyrupSY7b1492ef-c8ab-4776-97b1-5982d2ea69a01
310604guaifenesin 100 MG per 5 ML Oral SyrupSYdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 200 MG per 10 ML Oral SolutionSY7b1492ef-c8ab-4776-97b1-5982d2ea69a01
310604guaifenesin 200 MG per 10 ML Oral SolutionSYdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 300 MG per 15 ML Oral SolutionSY7b1492ef-c8ab-4776-97b1-5982d2ea69a01
310604guaifenesin 300 MG per 15 ML Oral SolutionSYdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 400 MG per 20 ML Oral SolutionSY7b1492ef-c8ab-4776-97b1-5982d2ea69a01
310604guaifenesin 400 MG per 20 ML Oral SolutionSYdb4a5925-e864-42ba-e053-2a95a90ad3811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-135-34493480135341 BOTTLE in 1 CARTON (49348-135-34) > 118 mL in 1 BOTTLE1 bottle2014-09-170000-00-00NoNoCurrent