aquafresh cavity protection

Generic: sodium fluoride

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name aquafresh cavity protection
Generic Name sodium fluoride
Labeler haleon us holdings llc
Dosage Form PASTE
Routes
DENTAL
Active Ingredients

sodium fluoride 1.15 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0590
Product ID 0135-0590_4af361ee-0754-8996-e063-6294a90aab2d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2027-12-31
Marketing Start 2016-10-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350590
Hyphenated Format 0135-0590

Supplemental Identifiers

RxCUI
1044547
UNII
8ZYQ1474W7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name aquafresh cavity protection (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 1.15 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0135-0590-01) / 158.8 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0135-0590-02) / 85 g in 1 TUBE
  • 2 TUBE in 1 CARTON (0135-0590-04) / 158.8 g in 1 TUBE
  • 3 TUBE in 1 CARTON (0135-0590-05) / 158.8 g in 1 TUBE
source: ndc

Packages (4)

0135-0590-01 1 TUBE in 1 CARTON (0135-0590-01) / 158.8 g in 1 TUBE 0135-0590-02 1 TUBE in 1 CARTON (0135-0590-02) / 85 g in 1 TUBE 0135-0590-04 2 TUBE in 1 CARTON (0135-0590-04) / 158.8 g in 1 TUBE 0135-0590-05 3 TUBE in 1 CARTON (0135-0590-05) / 158.8 g in 1 TUBE

Ingredients (1)

sodium fluoride (1.15 mg/g)

Linked Drug Pages (1)

AQUAFRESH CAVITY PROTECTION, AQUAFRESH EXTRA FRESH PLUS WHITENING ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "4af361ee-0754-8996-e063-6294a90aab2d", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["1044547"], "spl_set_id": ["5484999c-8e6f-430d-99a5-6893a2489467"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0135-0590-01)  / 158.8 g in 1 TUBE", "package_ndc": "0135-0590-01", "marketing_start_date": "20161001"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0135-0590-02)  / 85 g in 1 TUBE", "package_ndc": "0135-0590-02", "marketing_start_date": "20161101"}, {"sample": false, "description": "2 TUBE in 1 CARTON (0135-0590-04)  / 158.8 g in 1 TUBE", "package_ndc": "0135-0590-04", "marketing_start_date": "20161101"}, {"sample": false, "description": "3 TUBE in 1 CARTON (0135-0590-05)  / 158.8 g in 1 TUBE", "package_ndc": "0135-0590-05", "marketing_start_date": "20210228"}], "brand_name": "AQUAFRESH CAVITY PROTECTION", "product_id": "0135-0590_4af361ee-0754-8996-e063-6294a90aab2d", "dosage_form": "PASTE", "product_ndc": "0135-0590", "generic_name": "sodium fluoride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AQUAFRESH", "brand_name_suffix": "CAVITY PROTECTION", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "1.15 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20161001", "listing_expiration_date": "20271231"}