Home NDC 0362-3971 DycloPro
Product NDC 0362-3971
11-digit product format 003623971
Labeler code 0362
Product ID 0362-3971_639ddf01-a839-45be-b9a7-11f27394c799
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dyclonine Hydrochloride
Dosage form SOLUTION
Route TOPICAL
Labeler Septodont Inc
Application ANDA200480
Marketing category ANDA
Marketing start 2019-09-01
Substance DYCLONINE HYDROCHLORIDE
Active strength 5 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200480-001 DYCLOPRO DYCLONINE HYDROCHLORIDE 0.5% SOLUTION / TOPICAL RS 2018-11-20 A200480-002 DYCLOPRO DYCLONINE HYDROCHLORIDE 1% SOLUTION / TOPICAL RS 2018-11-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200480-001 DYCLOPRO 0.5% SOLUTION / TOPICAL RS 2018-11-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200480-002 DYCLOPRO 1% SOLUTION / TOPICAL RS 2018-11-20 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base DycloPro
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DYCLONINE HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZEC193879Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1048281 Internal RxNorm lookup 2199132 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0362-3971-05 DycloPro 1 in 1 BOTTLE SOLUTION 1 5 0362-3971-05 DycloPro 30 mL in 1 BOTTLE SOLUTION 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0362-3971 DYCLOPRO (DYCLONINE HYDROCHLORIDE) SOLUTION [SEPTODONT INC] 5 Current NDC, Legacy NDC, 2 package rows 20241130_bfd9a2dd-7b40-40c0-b256-52f613395760.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 1 of 1 · 1 matching rows.
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 0362-3971-05 00362397105 1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE 1 bottle 2019-09-01 0000-00-00 No No Current