Gracie Square Hospital Amenity
- Product NDC
- 59448-101
- 11-digit product format
- 594480101
- Labeler code
- 59448
- Product ID
- 59448-101_baaa5bdf-c58a-4b39-a6a6-dda6d98229fa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Monofluorophosphate
- Dosage form
- KIT
- Labeler
- ASP Global, LLc
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-01-18
- 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 | 59448-101 | 59448-101-00 | D | Discontinued by firm | 2026-10-05 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 59448-101-00 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 59448-101-00 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 59448-101-00 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 59448-101-00 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 59448-101-00 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 59448-101-00 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 59448-101-00 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 59448-101-00 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 59448-101-00 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 59448-101-00 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 59448-101-00 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 59448-101-00 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 59448-101-00 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 59448-101-00 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 59448-101-00 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 59448-101-00 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 59448-101-00 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 59448-101-00 | bd6a592717d7… | 303034d00443… |
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
- Gracie Square Hospital Amenity
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 545626 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 89d81053-6950-465e-a5b1-cbf841d7afcb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59448-101-00 | 2025-12-30 | C162847 | 48780-1 | d6a99b39-ec40-a426-e053-dadaa90af4c2 | Gracie Square Hospital Amenity Kit |
| 59448-101-00 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ec40-a426-e053-dadaa90af4c2 | Gracie Square Hospital Amenity Kit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59448-101-00 | Gracie Square Hospital Amenity | 1 in 1 BAG | KIT | 1 | 6 |
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 |
|---|---|---|---|---|---|---|
| Toms of Maine Tropical Island | ALUMINUM CHLOROHYDRATE | Tom's of Maine | ae6de376-76fd-4609-a2d5-7a902c0d4c5c | 2026-01-27 | Warnings | M021 |
| Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum) | SODIUM FLUORIDE | Made by Dentists Inc. | f3f6b32d-8e47-4f52-bd9a-20bd51c9d007 | 2026-01-27 | Warnings | M021 |
| Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape | SODIUM FLUORIDE | Ashtel Studios Inc. | 6c6d143f-4c2b-4207-bde7-9df8251616a3 | 2026-01-27 | Warnings | M021 |
| Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELON | SODIUM FLUORIDE | Ashtel Studios, Inc. | d80d0a87-5d1f-4114-977a-036ffed77205 | 2026-01-27 | Warnings | M021 |
| Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard Berry | SODIUM FLUORIDE | Ashtel Studios, Inc. | ac18dd0a-d476-48a7-8493-594a0293b926 | 2026-01-27 | Warnings | M021 |
| Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRY | SODIUM FLUORIDE | Ashtel Studios, Inc. | 2500e14e-6cf4-4ac4-810f-1ef163c5e474 | 2026-01-27 | Warnings | M021 |
| Hello Unicorn Splash | SODIUM FLUORIDE | Accupac LLC | 23807810-990a-b723-e063-6394a90aee3e | 2026-01-22 | Warnings | M021 |
| Colgate Cavity Protection Great Regular Flavor | ANTICAVITY FLUORIDE TOOTHPASTE | Colgate-Palmolive Company | 202c6c62-e16a-4716-babe-d5414006c79e | 2026-01-21 | Warnings | M021 |
| Crest 3D White Luxe Diamond Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c1420129-5460-4900-ac9a-356d2d7c60a2 | 2026-01-21 | Warnings | M021 |
| Crest Pro-Health Advanced Max Cavity and Erosion Prevention | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 48eb0bdc-7399-745d-e063-6294a90a9809 | 2026-01-21 | Warnings | M021 |
| Colgate Total Gum Protect Whitening | STANNOUS FLUORIDE | Colgate-Palmolive Company | dcf81dcb-b26b-4411-82d4-5f7e9d3fc0f3 | 2026-01-20 | Warnings | M021 |
| GuruNanda Anti-Cavity | SODIUM FLUORIDE | GURUNANDA, LLC | 3b07b72f-4efc-eb0f-e063-6294a90a70a8 | 2026-01-19 | Warnings | M021 |
| GuruNanda Anticavity | SODIUM FLUORIDE | GURUNANDA, LLC | 3e90d516-3172-3c8d-e063-6294a90a394f | 2026-01-19 | Warnings | M021 |
| Hismile | PEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0eba92d1-cbdc-9c96-e063-6294a90a9afc | 2026-01-15 | Warnings | M021 |
| Hismile | COCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3cfb6-6bae-1682-e063-6394a90aca88 | 2026-01-15 | Warnings | M021 |
| Hismile | MANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3f4f8-fdc4-2056-e063-6394a90a6fd7 | 2026-01-15 | Warnings | M021 |
| Hismile | SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef41051-dfa0-b105-e063-6294a90a551f | 2026-01-15 | Warnings | M021 |
| Hismile | WATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef43107-58ec-d4ee-e063-6294a90ad8d7 | 2026-01-15 | Warnings | M021 |
| Hismile | RED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef56539-dc21-c6ea-e063-6394a90a5790 | 2026-01-15 | Warnings | M021 |
| Hismile | GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef6f8b5-8565-b364-e063-6294a90aabbc | 2026-01-15 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 89d81053-6950-465e-a5b1-cbf841d7afcb | 6 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 89d81053-6950-465e-a5b1-cbf841d7afcb | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 89d81053-6950-465e-a5b1-cbf841d7afcb | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 89d81053-6950-465e-a5b1-cbf841d7afcb | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 89d81053-6950-465e-a5b1-cbf841d7afcb | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 89d81053-6950-465e-a5b1-cbf841d7afcb | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59448-101-00 | 59448010100 | 1 KIT in 1 BAG (59448-101-00) * 10 g in 1 TUBE (42555-060-45) * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE | 1 kit | 2016-01-18 | 0000-00-00 | No | No | Current |