Home NDC 0187-5198 Klaron
Product NDC 0187-5198
11-digit product format 001875198
Labeler code 0187
Product ID 0187-5198_4dd0038b-2f5d-436c-8a6d-6db44760c37a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulfacetamide sodium
Dosage form LOTION
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA019931
Marketing category NDA
Marketing start 1996-12-23
Substance SULFACETAMIDE SODIUM
Active strength 100 mg/mL
Pharmacologic classes Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019931-001 KLARON SULFACETAMIDE SODIUM 10% LOTION / TOPICAL AB RLD, RS 1996-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019931-001 AB
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 2 · 41 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 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019931-001 KLARON 10% LOTION / TOPICAL AB RLD, RS 1996-12-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Klaron
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFACETAMIDE SODIUM 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4NRT660KJQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1006688 Internal RxNorm lookup 1006693 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 0187-5198-04 Klaron 1 in 1 CARTON LOTION 1 7 0187-5198-04 Klaron 118 mL in 1 BOTTLE, PLASTIC LOTION 118 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-5198 KLARON (SULFACETAMIDE SODIUM) LOTION [BAUSCH HEALTH US, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20200930_66ab38ea-5cea-47be-97f2-486517999fb0.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0187-5198-04 00187519804 1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) / 118 mL in 1 BOTTLE, PLASTIC 1996-12-23 0000-00-00 No No Current