Home NDC 61037-414 Chlorhexidine Gluconate Solution 0.75% Antiseptic
Product NDC 61037-414
11-digit product format 610370414
Labeler code 61037
Product ID 61037-414_f0b7b337-be39-2e5f-e053-2995a90a3c8c
Type HUMAN OTC DRUG
Nonproprietary name Chlorhexidine Gluconate Solution 0.75% Antiseptic
Dosage form SOLUTION
Route TOPICAL
Labeler Bajaj Medical, LLC
Application NDA020111
Marketing category NDA
Marketing start 2014-09-30
Substance CHLORHEXIDINE GLUCONATE
Active strength .75 mg/100mL
Pharmacologic classes Decreased Cell Wall Integrity [PE]
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 N020111-001 CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11
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 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020111-001 CHLORHEXIDINE GLUCONATE 0.75% SOLUTION / TOPICAL 1997-09-11 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Chlorhexidine Gluconate Solution 0.75% Antiseptic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORHEXIDINE GLUCONATE .75 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MOR84MUD8E Internal UNII 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 61037-414-01 Chlorhexidine Gluconate Solution 0.75% Antiseptic 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 15 61037-414-02 Chlorhexidine Gluconate Solution 0.75% Antiseptic 236 mL in 1 BOTTLE, PLASTIC SOLUTION 236 15 61037-414-03 Chlorhexidine Gluconate Solution 0.75% Antiseptic 236 mL in 1 BOTTLE, PUMP SOLUTION 236 15 61037-414-04 Chlorhexidine Gluconate Solution 0.75% Antiseptic 236 mL in 1 BOTTLE, PUMP SOLUTION 236 15 61037-414-05 Chlorhexidine Gluconate Solution 0.75% Antiseptic 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 15 61037-414-06 Chlorhexidine Gluconate Solution 0.75% Antiseptic 946 mL in 1 BOTTLE, PLASTIC SOLUTION 946 15 61037-414-07 Chlorhexidine Gluconate Solution 0.75% Antiseptic 3785 mL in 1 JUG SOLUTION 3785 15 61037-414-08 Chlorhexidine Gluconate Solution 0.75% Antiseptic 1200 mL in 1 BOTTLE, DISPENSING SOLUTION 1200 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORHEXIDINE GLUCONATE ACTIVE INGREDIENT MOR84MUD8E DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 CHLORHEXIDINE ACTIVE MOIETY R4KO0DY52L DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 COCO DIETHANOLAMIDE INACTIVE INGREDIENT 92005F972D DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 FD&C RED NO. 4 INACTIVE INGREDIENT X3W0AM1JLX DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 HYDROXYETHYL CELLULOSE (140 CPS AT 5%) INACTIVE INGREDIENT 8136Y38GY5 DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 LAURAMINE OXIDE INACTIVE INGREDIENT 4F6FC4MI8W DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE INACTIVE INGREDIENT 93OU7D1C3U DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DYNA-HEX 75 (ANTISEPTIC HANDWASH) SOLUTION [BAJAJ MEDICAL, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61037-414 CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC SOLUTION [BAJAJ MEDICAL, LLC] 15 Current NDC, Legacy NDC, 8 package rows 20221227_014a5f36-0396-498b-901f-9a86df4e11fe.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61037-414-01 61037041401 118 mL in 1 BOTTLE, PLASTIC (61037-414-01) 118 ml 2014-09-30 0000-00-00 No No Current 61037-414-02 61037041402 236 mL in 1 BOTTLE, PLASTIC (61037-414-02) 236 ml 2014-09-30 0000-00-00 No No Current 61037-414-03 61037041403 236 mL in 1 BOTTLE, PUMP (61037-414-03) 236 ml 2017-10-12 0000-00-00 No No Current 61037-414-04 61037041404 236 mL in 1 BOTTLE, PUMP (61037-414-04) 236 ml 2017-10-12 0000-00-00 No No Current 61037-414-05 61037041405 473 mL in 1 BOTTLE, PLASTIC (61037-414-05) 473 ml 2014-09-30 0000-00-00 No No Current 61037-414-06 61037041406 946 mL in 1 BOTTLE, PLASTIC (61037-414-06) 946 ml 2014-09-30 0000-00-00 No No Current 61037-414-07 61037041407 3785 mL in 1 JUG (61037-414-07) 3785 ml 2014-09-30 0000-00-00 No No Current 61037-414-08 61037041408 1200 mL in 1 BOTTLE, DISPENSING (61037-414-08) 1200 ml 2017-10-12 0000-00-00 No No Current