FDA.reportPublic FDA data

GuruNanda Anti-Gingivitis

Product NDC
70708-012
11-digit product format
707080012
Labeler code
70708
Product ID
70708-012_48c6ad9a-d872-a2c6-e063-6394a90a2581
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
RINSE
Route
ORAL
Labeler
GURUNANDA, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.05 g/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 Anti-GingivitisCETYLPYRIDINIUM CHLORIDEGURUNANDA, LLC386f8d92-8186-eed7-e063-6394a90a87e12026-01-19WarningsExact 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 increasing spacing between the teeth. These may be signs or symptoms of periodontits, 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 Anti-Gingivitis
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.05 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD9OM4SK49P
Rxcui1251617

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70708-012-16GuruNanda Anti-Gingivitis473 mL in 1 BOTTLERINSE4736
70708-012-24GuruNanda Anti-Gingivitis710 mL in 1 BOTTLERINSE7106
70708-012-33GuruNanda Anti-Gingivitis999 mL in 1 BOTTLERINSE9996

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN386f8d92-8186-eed7-e063-6394a90a87e16
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD386f8d92-8186-eed7-e063-6394a90a87e16
1251617cetylpyridinium chloride 0.05 % MouthwashSY386f8d92-8186-eed7-e063-6394a90a87e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70708-012-1670708001216473 mL in 1 BOTTLE (70708-012-16) 473 ml2025-08-01NoNoCurrent
70708-012-2470708001224710 mL in 1 BOTTLE (70708-012-24) 710 ml2025-08-01NoNoCurrent
70708-012-3370708001233999 mL in 1 BOTTLE (70708-012-33) 999 ml2025-08-01NoNoCurrent