Crest Pro-Health
- Product NDC
- 69423-765
- 11-digit product format
- 694230765
- Labeler code
- 69423
- Product ID
- 69423-765_47e317c2-ea4d-8cce-e063-6394a90a9182
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Stannous Fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-01
- Substance
- STANNOUS FLUORIDE
- Active strength
- 1.5 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 69423-765 | 69423-765-16 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 69423-765 | 69423-765-28 | D | Discontinued by firm | 2026-10-12 |
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.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 69423-765-28 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 69423-765-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 69423-765-28 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 69423-765-16 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Crest Pro-Health
- Brand name suffix
- Sensitive and Gum All Day Protection
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | 1.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 416784 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f4d775a1-a4f6-cd69-e053-2995a90a5f64 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69423-765-03 | Crest Pro-HealthSensitive and Gum All Day Protection | 136 g in 1 TUBE | PASTE, DENTIFRICE | 136 | 9 | |
| 69423-765-03 | Crest Pro-HealthSensitive and Gum All Day Protection | 3 in 1 CARTON | PASTE, DENTIFRICE | 3 | 9 | |
| 69423-765-16 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-16 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CELLO PACK | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-28 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-28 | Crest Pro-HealthSensitive and Gum All Day Protection | 79 g in 1 TUBE | PASTE, DENTIFRICE | 79 | 9 | |
| 69423-765-33 | Crest Pro-HealthSensitive and Gum All Day Protection | 3 in 1 CELLO PACK | PASTE, DENTIFRICE | 3 | 9 | |
| 69423-765-33 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-37 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-37 | Crest Pro-HealthSensitive and Gum All Day Protection | 104 g in 1 TUBE | PASTE, DENTIFRICE | 104 | 9 | |
| 69423-765-41 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-41 | Crest Pro-HealthSensitive and Gum All Day Protection | 116 g in 1 TUBE | PASTE, DENTIFRICE | 116 | 9 | |
| 69423-765-46 | Crest Pro-HealthSensitive and Gum All Day Protection | 130 g in 1 TUBE | PASTE, DENTIFRICE | 130 | 9 | |
| 69423-765-46 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-48 | Crest Pro-HealthSensitive and Gum All Day Protection | 136 g in 1 TUBE | PASTE, DENTIFRICE | 136 | 9 | |
| 69423-765-48 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-52 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-52 | Crest Pro-HealthSensitive and Gum All Day Protection | 147 g in 1 TUBE | PASTE, DENTIFRICE | 147 | 9 | |
| 69423-765-85 | Crest Pro-HealthSensitive and Gum All Day Protection | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 9 | |
| 69423-765-85 | Crest Pro-HealthSensitive and Gum All Day Protection | 24 g in 1 TUBE | PASTE, DENTIFRICE | 24 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69423-765 | CREST PRO-HEALTH SENSITIVE AND GUM ALL DAY PROTECTION (STANNOUS FLUORIDE) PASTE, DENTIFRICE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 7 | Current NDC, 20 package rows | 20250125_f4d775a1-a4f6-cd69-e053-2995a90a5f64.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Walgreens Restore and Defend | STANNOUS FLUORIDE | Walgreens | e808ea4b-9081-085b-e053-2a95a90a4f9b | 2026-06-02 | Warnings | M021 |
| Hello Unicorn Splash unicorn splash anticavity fluoride rinse | SODIUM FLUORIDE | Colgate-Palmolive Company | a1014431-7d23-aaff-6dc7-ab58683d0338 | 2026-06-02 | Warnings | M021 |
| Therabreath Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | feab3d45-ff95-4b32-8258-7d932a7380c9 | 2026-06-01 | Warnings | M021 |
| Orajel Toy Story 5 Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b80947d-f389-2f80-e063-6294a90abd55 | 2026-06-01 | Warnings | M021 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 54113245-0c1e-739e-e063-6294a90aea42 | 2026-06-01 | Warnings | M021 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 545258fd-8179-fffc-e063-6394a90a467f | 2026-06-01 | Warnings | M021 |
| Orajel Paw Patrol | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d87bea-3e99-5d04-e053-2a95a90aaf54 | 2026-06-01 | Warnings | M021 |
| Orajel SuperMario | ANTICAVITY TOOTHPASTE | Church & Dwight Co., Inc. | 27d2f6cb-8661-da9c-e063-6394a90a5bde | 2026-06-01 | Warnings | M021 |
| Orajel KidsToothpaste | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d62125-c2c5-5926-e053-2995a90aaa29 | 2026-06-01 | Warnings | M021 |
| AIM CAVITY PROTECTION Multi Benefit | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0f8a33-0b01-40e2-e054-00144ff88e88 | 2026-06-01 | Warnings | M021 |
| Crest plus Tartar Protection Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 560980ea-749f-593d-e063-6394a90a1b9e | 2026-06-01 | Warnings | M021 |
| Colgate Revitalizing White | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | c67223ae-b068-41c5-a15b-7ae9840b93ef | 2026-05-27 | Warnings | M021 |
| Colgate Kids Harry Potter | SODIUM FLUORIDE | Colgate-Palmolive Company | 61c06da4-9f02-4fbc-b80f-1c443e298496 | 2026-05-26 | Warnings | M021 |
| sodium fluoride rinse | SODIUM FLUORIDE RINSE | Rockland Cosmetics, Inc. | 52430b12-4d5f-d1e1-e063-6394a90abd64 | 2026-05-20 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | H E B | d0a52519-3339-40ea-93e5-78f76d348a4d | 2026-05-14 | Warnings, Adverse reactions | M021 |
| Burts Bees Extra White | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c92524fd-8b93-592d-e053-2a95a90a88c6 | 2026-05-13 | Warnings | M021 |
| MIPaste Plus Strawberry | SODIUM FLUORIDE | GC America Inc. | 1b68bd67-65d3-4c64-e054-00144ff8d46c | 2026-05-12 | Warnings | M021 |
| White Glo Purple Color Corrector Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 6f8b77c3-9833-4c75-b41c-a2bc12616157 | 2026-05-12 | Warnings | M021 |
| botalab HERBAL COMPLETE TOOTH | SODIUM FLUORIDE | KMPHARMACEUTICAL CO., LTD. | 51365ef7-ed94-2650-e063-6394a90ab89e | 2026-05-07 | Warnings | M021 |
| Morning Fresh Mint Toothpaste, with Fluoride | MORNING FRESH MINT TOOTHPASTE, WITH FLUORIDE | Dynarex Corporation | 2a42d8ce-e7f2-caa5-e063-6294a90ac01f | 2026-05-07 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | PSN | f4d775a1-a4f6-cd69-e053-2995a90a5f64 | 9 |
| 416784 | stannous fluoride 0.00454 MG/MG Toothpaste | SCD | f4d775a1-a4f6-cd69-e053-2995a90a5f64 | 9 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste | SY | f4d775a1-a4f6-cd69-e053-2995a90a5f64 | 9 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste | SY | f4d775a1-a4f6-cd69-e053-2995a90a5f64 | 9 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | SY | f4d775a1-a4f6-cd69-e053-2995a90a5f64 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69423-765-03 | 69423076503 | 3 TUBE in 1 CARTON (69423-765-03) / 136 g in 1 TUBE | 3 tube | 2023-01-01 | No | No | Current |
| 69423-765-16 | 69423076516 | 1 in 1 CARTON | Historical | ||||
| 69423-765-28 | 69423076528 | 1 in 1 CARTON | Historical | ||||
| 69423-765-33 | 69423076533 | 3 CARTON in 1 CELLO PACK (69423-765-33) / 1 TUBE in 1 CARTON / 104 g in 1 TUBE | 3 carton | 2023-01-01 | No | No | Current |
| 69423-765-37 | 69423076537 | 1 TUBE in 1 CARTON (69423-765-37) / 104 g in 1 TUBE | 1 tube | 2023-02-16 | No | No | Current |
| 69423-765-41 | 69423076541 | 1 TUBE in 1 CARTON (69423-765-41) / 116 g in 1 TUBE | 1 tube | 2023-02-16 | No | No | Current |
| 69423-765-46 | 69423076546 | 1 TUBE in 1 CARTON (69423-765-46) / 130 g in 1 TUBE | 1 tube | 2023-02-16 | No | No | Current |
| 69423-765-48 | 69423076548 | 1 TUBE in 1 CARTON (69423-765-48) / 136 g in 1 TUBE | 1 tube | 2023-02-16 | No | No | Current |
| 69423-765-52 | 69423076552 | 1 TUBE in 1 CARTON (69423-765-52) / 147 g in 1 TUBE | 1 tube | 2023-02-16 | No | No | Current |
| 69423-765-85 | 69423076585 | 1 TUBE in 1 CARTON (69423-765-85) / 24 g in 1 TUBE | 1 tube | 2024-04-01 | No | No | Current |