Respiratory Relief

Product NDC
53499-5295
11-digit product format
534995295
Labeler code
53499
Product ID
53499-5295_6465861b-e970-4f26-8c90-2ee4a6323723
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET
Route
ORAL
Labeler
Schwabe North America, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-29
Substance
GUAIFENESIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Respiratory Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui359601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5295-0Respiratory Relief30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNf683041a-4ff9-42a5-9047-a9a3140a87581
359601guaifenesin 400 MG Oral TabletSCDf683041a-4ff9-42a5-9047-a9a3140a87581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-5295-05349952950030 TABLET in 1 BOTTLE (53499-5295-0) 30 tablet2025-07-29NoNoHistorical