Home NDC 68400-138 Gelato Neutral PH
Product NDC 68400-138
11-digit product format 684000138
Labeler code 68400
Product ID 68400-138_202c46b4-9136-4bce-8cee-82718ebb3818
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form AEROSOL, FOAM
Route DENTAL; ORAL; TOPICAL
Labeler Deepak Products, inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-08-11
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 3 g/125g
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68400-138-04 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68400-138-04 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68400-138-04 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68400-138-04 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68400-138-04 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68400-138-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68400-138-04 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68400-138-04 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68400-138-04 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68400-138-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68400-138-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68400-138-04 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68400-138-04 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68400-138-04 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68400-138-04 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68400-138-04 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68400-138-04 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68400-138-04 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68400-138-04 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68400-138-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68400-138-04 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68400-138-04 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68400-138-04 Gelato Neutral PH 125 g in 1 BOTTLE, SPRAY AEROSOL, FOAM 125 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 FLUORIDE ION ACTIVE MOIETY Q80VPU408O GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 DECYL GLUCOSIDE INACTIVE INGREDIENT Z17H97EA6Y GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 DMDM HYDANTOIN INACTIVE INGREDIENT BYR0546TOW GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 HYDROFLUORIC ACID INACTIVE INGREDIENT RGL5YE86CZ GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68400-138 GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] 3 Legacy NDC, 1 package rows 20110819_ba5c415e-2a44-4b49-b85a-55984e3131b8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 68400-138-04 68400013804 125 g in 1 BOTTLE, SPRAY 125 g Historical