Colgate Total SF Whitening Gel
- Product NDC
- 35000-175
- 11-digit product format
- 350000175
- Labeler code
- 35000
- Product ID
- 35000-175_63eccf8c-eaf0-431c-9b77-14475d78403b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Stannous Fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Colgate-Palmolive Company
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-11-01
- Marketing end
- 2026-12-31
- Substance
- STANNOUS FLUORIDE
- Active strength
- 1.1 mg/g
- NDC exclude flag
- No
- 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 | 35000-175 | 35000-175-48 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 35000-175 | 35000-175-78 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 35000-175 | 35000-175-95 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 35000-175 | 35000-175-96 | D | Discontinued by firm | 2026-10-15 |
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 | 35000-175-95 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 35000-175-78 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 35000-175-48 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 35000-175-96 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-175-95 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-175-78 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-175-48 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-175-96 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-175-95 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-175-78 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-175-48 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-175-96 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-175-95 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-175-78 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-175-48 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-175-96 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-175-95 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-175-78 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-175-48 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-175-96 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-175-95 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-175-78 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-175-48 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-175-96 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-175-95 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-175-78 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-175-48 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-175-96 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-175-95 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-175-78 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-175-48 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-175-96 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-175-95 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-175-78 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-175-48 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-175-96 | 0efc9e666f02… | f202fb6c5f17… |
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
- Colgate Total SF Whitening Gel
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | 1.1 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 |
|---|---|
| 27c4eed5-9121-4e09-9d42-e0a3e8430109 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35000-175-32 | Colgate Total SF Whitening Gel | 93 g in 1 TUBE | PASTE, DENTIFRICE | 93 | 12 | |
| 35000-175-32 | Colgate Total SF Whitening Gel | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 12 | |
| 35000-175-48 | Colgate Total SF Whitening Gel | 136 g in 1 TUBE | PASTE, DENTIFRICE | 136 | 12 | |
| 35000-175-48 | Colgate Total SF Whitening Gel | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 12 | |
| 35000-175-60 | Colgate Total SF Whitening Gel | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 12 | |
| 35000-175-60 | Colgate Total SF Whitening Gel | 170 g in 1 TUBE | PASTE, DENTIFRICE | 170 | 12 | |
| 35000-175-65 | Colgate Total SF Whitening Gel | 2 in 1 CARTON | PASTE, DENTIFRICE | 2 | 12 | |
| 35000-175-65 | Colgate Total SF Whitening Gel | 144 g in 1 TUBE | PASTE, DENTIFRICE | 144 | 12 | |
| 35000-175-66 | Colgate Total SF Whitening Gel | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 12 | |
| 35000-175-66 | Colgate Total SF Whitening Gel | 144 g in 1 TUBE | PASTE, DENTIFRICE | 144 | 12 | |
| 35000-175-78 | Colgate Total SF Whitening Gel | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 12 | |
| 35000-175-78 | Colgate Total SF Whitening Gel | 221 g in 1 TUBE | PASTE, DENTIFRICE | 221 | 12 | |
| 35000-175-95 | Colgate Total SF Whitening Gel | 178 g in 1 TUBE | PASTE, DENTIFRICE | 178 | 12 | |
| 35000-175-95 | Colgate Total SF Whitening Gel | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 12 | |
| 35000-175-96 | Colgate Total SF Whitening Gel | 136 g in 1 TUBE | PASTE, DENTIFRICE | 136 | 12 | |
| 35000-175-96 | Colgate Total SF Whitening Gel | 2 in 1 CARTON | PASTE, DENTIFRICE | 2 | 12 |
DailyMed Dashboard NDC Coverage#
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 | 27c4eed5-9121-4e09-9d42-e0a3e8430109 | 12 |
| 416784 | stannous fluoride 0.00454 MG/MG Toothpaste | SCD | 27c4eed5-9121-4e09-9d42-e0a3e8430109 | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste | SY | 27c4eed5-9121-4e09-9d42-e0a3e8430109 | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste | SY | 27c4eed5-9121-4e09-9d42-e0a3e8430109 | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | SY | 27c4eed5-9121-4e09-9d42-e0a3e8430109 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 35000-175-32 | 35000017532 | 1 TUBE in 1 CARTON (35000-175-32) / 93 g in 1 TUBE | 1 tube | 2018-11-01 | 2026-12-31 | No | No | Current |
| 35000-175-48 | 35000017548 | 1 TUBE in 1 CARTON (35000-175-48) > 136 g in 1 TUBE | 1 tube | 2018-11-01 | 0000-00-00 | No | No | Current |
| 35000-175-60 | 35000017560 | 1 TUBE in 1 CARTON (35000-175-60) / 170 g in 1 TUBE | 1 tube | 2021-02-10 | 2026-12-31 | No | No | Current |
| 35000-175-65 | 35000017565 | 2 TUBE in 1 CARTON (35000-175-65) / 144 g in 1 TUBE | 2 tube | 2021-12-01 | 2026-12-31 | No | No | Current |
| 35000-175-66 | 35000017566 | 1 TUBE in 1 CARTON (35000-175-66) / 144 g in 1 TUBE | 1 tube | 2021-12-27 | 2026-12-31 | No | No | Current |
| 35000-175-78 | 35000017578 | 1 TUBE in 1 CARTON (35000-175-78) > 221 g in 1 TUBE | 1 tube | 2018-11-01 | 0000-00-00 | No | No | Current |
| 35000-175-95 | 35000017595 | 1 TUBE in 1 CARTON (35000-175-95) > 178 g in 1 TUBE | 1 tube | 2018-11-01 | 0000-00-00 | No | No | Current |
| 35000-175-96 | 35000017596 | 2 TUBE in 1 CARTON (35000-175-96) > 136 g in 1 TUBE | 2 tube | 2018-11-01 | 0000-00-00 | No | No | Current |