Home NDC 59448-101-00 Gracie Square Hospital Amenity
Product NDC 59448-101
Requested package NDC 59448-101-00
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 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.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 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# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table 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# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59448-101 GRACIE SQUARE HOSPITAL AMENITY (SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20190917_89d81053-6950-465e-a5b1-cbf841d7afcb.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.
Matched openFDA labels page 40 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DawnMist TOOTHPASTE Dukal LLC 147f7738-5080-9907-e063-6294a90a6170 2025-02-07 Warnings Exact identifier application number: M021 DawnMist Gel Fluoride GEL FLUORIDE TOOTHPASTE Dukal LLC 14443184-1694-70b9-e063-6394a90a86fe 2025-02-07 Warnings Exact identifier application number: M021 Quip Anticavity Fluoride Concentrate SODIUM FLUORIDE Quip NYC Inc. b3da65bb-0871-34e7-e053-2a95a90a310e 2025-01-30 Warnings Exact identifier application number: M021 Quip Anticavity SODIUM FLUORIDE Quip NYC Inc. b6d4cfe3-535e-9163-e053-2a95a90ae140 2025-01-30 Warnings Exact identifier application number: M021 Quip Anticavity SODIUM FLUORIDE Quip NYC Inc. b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a 2025-01-30 Warnings Exact identifier application number: M021 Quip SODIUM FLUORIDE Quip NYC Inc. 714b7205-444d-929b-e053-2995a90a958e 2025-01-30 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DOCSMEDI Co., Ltd. ea18ac56-4ef1-4bf0-8c26-6885183fd684 2025-01-22 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DOCSMEDI Co., Ltd. aaf08481-a2ff-48f6-8611-73a469efe1db 2025-01-22 Warnings Exact identifier application number: M021 Double X CONCENTRATED CETYLPYRIDINIUM CHLORIDE DOCSMEDI Co., Ltd. 411be334-364c-4074-8d0b-8dda332f87de 2025-01-22 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude d33e3778-ba1d-4560-bafa-74f7ab88c6b5 2025-01-20 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE gel SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 86279b4d-82e5-45b5-9ba7-94fe3620b850 2025-01-16 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 2025-01-16 Warnings Exact identifier application number: M021 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 2025-01-16 Warnings Exact identifier application number: M021 Medpride SODIUM MONOFLUOROPHOSPHATE Shield Line LLC 9c1b0420-6b57-4914-99fe-df6a494815c3 2025-01-16 Warnings Exact identifier application number: M021 Sodium Fluoride SODIUM FLUORIDE Safco Dental Supply LLC 7a295974-c400-4442-9149-138a805ffb20 2025-01-09 Warnings Exact identifier application number: M021 Salivea FLUORIDE TOOTHPASTE Laclede, Inc. 6398ae96-dd38-44da-bc34-1d4d4c4a78ca 2025-01-08 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 098a29d5-3836-d362-e063-6394a90a9fea 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Sensitivity Care Prebiotic Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Sensitive Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. dec29c9f-6ddb-0b4e-e053-2995a90a64b1 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Original Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8e5de76b-535a-9c95-e053-2995a90afcab 2025-01-01 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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