FDA.reportPublic FDA data

GuruNanda Healthy Gums

Product NDC
70708-926
11-digit product format
707080926
Labeler code
70708
Product ID
70708-926_4f0fc291-d870-3663-e063-6394a90a918b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
GURUNANDA, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuruNanda Healthy GumsCETYLPYRIDINIUM CHLORIDEGURUNANDA, LLC3e90abec-44f4-e378-e063-6294a90a50fb2026-04-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Warnings Stop use and ask a dentist if Gingivitis, bleeding, or redness persists for more than 2 weeks You have painful or swollen gums, pus from the gum line, loose teeth, or icnreasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Additional Listing Data#

Finished product
Yes
Brand name base
GuruNanda Healthy Gums
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1291375

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70708-926-16GuruNanda Healthy Gums500 mL in 1 BOTTLE, PLASTICMOUTHWASH5005
70708-926-33GuruNanda Healthy Gums1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291375cetylpyridinium chloride 0.1 % MouthwashPSN3e90abec-44f4-e378-e063-6294a90a50fb5
1291375cetylpyridinium chloride 1 MG/ML MouthwashSCD3e90abec-44f4-e378-e063-6294a90a50fb5
1291375cetylpyridinium chloride 0.1 % MouthwashSY3e90abec-44f4-e378-e063-6294a90a50fb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70708-926-1670708092616500 mL in 1 BOTTLE, PLASTIC (70708-926-16) 500 ml2025-09-01NoNoCurrent
70708-926-33707080926331000 mL in 1 BOTTLE, PLASTIC (70708-926-33) 1000 ml2026-03-19NoNoCurrent