Home NDC 59428-500 Zapotol Dentidol Oral Analgesic
Product NDC 59428-500
11-digit product format 594280500
Labeler code 59428
Product ID 59428-500_c8332db3-9bef-41d6-b5f7-2a8584f0ee7b
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine, and Benzalkonium chloride
Dosage form GEL
Route TOPICAL
Labeler Productos Zapotol Corp.
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-05-18
Marketing end 0000-00-00
Substance BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength 20 g/100g; g/100g
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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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 59428-500-42 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.
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 59428-500-42 Zapotol Dentidol Oral Analgesic 1 in 1 PACKAGE GEL 1 2 59428-500-42 Zapotol Dentidol Oral Analgesic 11.9 g in 1 CARTON GEL 11.9 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZALKONIUM CHLORIDE ACTIVE INGREDIENT F5UM2KM3W7 ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 BENZOCAINE ACTIVE INGREDIENT U3RSY48JW5 ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 BENZALKONIUM ACTIVE MOIETY 7N6JUD5X6Y ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 BENZOCAINE ACTIVE MOIETY U3RSY48JW5 ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59428-500 ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.] 2 Legacy NDC, 2 package rows 20161102_1368d8bd-4263-4d8f-8a44-20571a8d6f8c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 59428-500-42 59428050042 1 in 1 PACKAGE Historical