COLGATE Great Regular Flavor
- Product NDC
- 35000-913
- 11-digit product format
- 350000913
- Labeler code
- 35000
- Product ID
- 35000-913_47460974-c56a-4db6-9ebb-5fbdecbbb067
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SODIUM MONOFLUOROPHOSPHATE
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Colgate-Palmolive Company
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-11-05
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 1 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 35000-913 | 35000-913-33 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 35000-913 | 35000-913-46 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 35000-913 | 35000-913-60 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 35000-913 | 35000-913-64 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 35000-913 | 35000-913-79 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 35000-913 | 35000-913-82 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 35000-913 | 35000-913-93 | D | Discontinued by firm | 2026-08-10 |
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 | 35000-913-46 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 35000-913-93 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 35000-913-64 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 35000-913-82 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 35000-913-33 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 35000-913-79 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-913-46 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-913-93 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-913-64 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-913-82 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-913-33 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 35000-913-79 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-913-46 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-913-93 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-913-64 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-913-82 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-913-33 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 35000-913-79 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-913-46 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-913-93 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-913-64 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-913-82 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-913-33 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 35000-913-79 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-913-46 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-913-93 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-913-64 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-913-82 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-913-33 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 35000-913-79 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-913-46 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-913-93 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-913-64 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-913-82 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-913-33 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 35000-913-79 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-913-46 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-913-93 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-913-64 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-913-82 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-913-33 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 35000-913-79 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-913-46 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-913-93 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-913-64 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-913-82 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-913-33 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 35000-913-79 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-913-46 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-913-93 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-913-64 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-913-82 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-913-33 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 35000-913-79 | 0efc9e666f02… | f202fb6c5f17… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COLGATE Great Regular Flavor
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM MONOFLUOROPHOSPHATE | 1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C810JCZ56Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 545626 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 730f40f6-6ac6-49bd-888b-c0b5818a03c8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35000-913-01 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-01 | COLGATE Great Regular Flavor | 28 g in 1 TUBE | PASTE, DENTIFRICE | 28 | 3 | |
| 35000-913-04 | COLGATE Great Regular Flavor | 4.25 g in 1 POUCH | PASTE, DENTIFRICE | 4.25 | 3 | |
| 35000-913-20 | COLGATE Great Regular Flavor | 24 g in 1 TUBE | PASTE, DENTIFRICE | 24 | 3 | |
| 35000-913-30 | COLGATE Great Regular Flavor | 170 g in 1 TUBE | PASTE, DENTIFRICE | 170 | 3 | |
| 35000-913-30 | COLGATE Great Regular Flavor | 3 in 1 CARTON | PASTE, DENTIFRICE | 3 | 3 | |
| 35000-913-33 | COLGATE Great Regular Flavor | 36.8 g in 1 TUBE | PASTE, DENTIFRICE | 36.8 | 3 | |
| 35000-913-33 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-46 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-46 | COLGATE Great Regular Flavor | 130 g in 1 TUBE | PASTE, DENTIFRICE | 130 | 3 | |
| 35000-913-48 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-48 | COLGATE Great Regular Flavor | 226 g in 1 TUBE | PASTE, DENTIFRICE | 226 | 3 | |
| 35000-913-58 | COLGATE Great Regular Flavor | 70 g in 1 TUBE | PASTE, DENTIFRICE | 70 | 3 | |
| 35000-913-58 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-60 | COLGATE Great Regular Flavor | 170 g in 1 TUBE | PASTE, DENTIFRICE | 170 | 3 | |
| 35000-913-64 | COLGATE Great Regular Flavor | 181 g in 1 TUBE | PASTE, DENTIFRICE | 181 | 3 | |
| 35000-913-64 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-69 | COLGATE Great Regular Flavor | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 3 | |
| 35000-913-69 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-79 | COLGATE Great Regular Flavor | 79 g in 1 TUBE | PASTE, DENTIFRICE | 79 | 3 | |
| 35000-913-79 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-82 | COLGATE Great Regular Flavor | 232 g in 1 TUBE | PASTE, DENTIFRICE | 232 | 3 | |
| 35000-913-82 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-92 | COLGATE Great Regular Flavor | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 35000-913-92 | COLGATE Great Regular Flavor | 141 g in 1 TUBE | PASTE, DENTIFRICE | 141 | 3 | |
| 35000-913-93 | COLGATE Great Regular Flavor | 99 g in 1 TUBE | PASTE, DENTIFRICE | 99 | 3 |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 730f40f6-6ac6-49bd-888b-c0b5818a03c8 | 3 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 730f40f6-6ac6-49bd-888b-c0b5818a03c8 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 730f40f6-6ac6-49bd-888b-c0b5818a03c8 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 730f40f6-6ac6-49bd-888b-c0b5818a03c8 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 730f40f6-6ac6-49bd-888b-c0b5818a03c8 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 730f40f6-6ac6-49bd-888b-c0b5818a03c8 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | f89bf259-b738-8229-e053-6394a90a0c59 | 2 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | f89bf259-b738-8229-e053-6394a90a0c59 | 2 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | f89bf259-b738-8229-e053-6394a90a0c59 | 2 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | f89bf259-b738-8229-e053-6394a90a0c59 | 2 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | f89bf259-b738-8229-e053-6394a90a0c59 | 2 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | f89bf259-b738-8229-e053-6394a90a0c59 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 35000-913-01 | 35000091301 | 1 TUBE in 1 CARTON (35000-913-01) / 28 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-04 | 35000091304 | 4.25 g in 1 POUCH (35000-913-04) | 4.25 g | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-20 | 35000091320 | 24 g in 1 TUBE (35000-913-20) | 24 g | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-30 | 35000091330 | 3 TUBE in 1 CARTON (35000-913-30) / 170 g in 1 TUBE | 3 tube | 2005-11-05 | No | No | Current | |
| 35000-913-33 | 35000091333 | 1 TUBE in 1 CARTON (35000-913-33) > 36.8 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-34 | 35000091334 | 2 TUBE in 1 CARTON (35000-913-34) / 170 g in 1 TUBE | 2 tube | 2024-01-01 | 0 | Current | ||
| 35000-913-46 | 35000091346 | 1 TUBE in 1 CARTON (35000-913-46) > 130 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-48 | 35000091348 | 1 TUBE in 1 CARTON (35000-913-48) / 226 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-58 | 35000091358 | 1 TUBE in 1 CARTON (35000-913-58) / 70 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-60 | 35000091360 | 170 g in 1 TUBE (35000-913-60) | 170 g | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-62 | 35000091362 | 1 TUBE in 1 CARTON (35000-913-62) / 170 g in 1 TUBE | 1 tube | 2026-01-01 | 0 | Current | ||
| 35000-913-64 | 35000091364 | 1 TUBE in 1 CARTON (35000-913-64) > 181 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-69 | 35000091369 | 1 TUBE in 1 CARTON (35000-913-69) / 113 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-79 | 35000091379 | 1 TUBE in 1 CARTON (35000-913-79) > 79 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-82 | 35000091382 | 1 TUBE in 1 CARTON (35000-913-82) > 232 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-92 | 35000091392 | 1 TUBE in 1 CARTON (35000-913-92) / 141 g in 1 TUBE | 1 tube | 2005-11-05 | 0000-00-00 | No | No | Current |
| 35000-913-93 | 35000091393 | 99 g in 1 TUBE (35000-913-93) | 99 g | 2005-11-05 | 0000-00-00 | No | No | Current |