Home NDC 52380-1919 Aplicare Chlorhexidine Gluconate 2% Solution
Product NDC 52380-1919
11-digit product format 523801919
Labeler code 52380
Product ID 52380-1919_9d2086f3-8e32-cbbb-e053-2a95a90acb51
Type HUMAN OTC DRUG
Nonproprietary name Chlorhexidine Gluconate
Dosage form SOLUTION
Route TOPICAL
Labeler Aplicare Products, LLC.
Application NDA019422
Marketing category NDA
Marketing start 1998-09-01
Marketing end 2021-07-01
Substance CHLORHEXIDINE GLUCONATE
Active strength 2 g/100mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 52380-1919 D Discontinued by firm 2026-07-31 excluded package package 52380-1919 52380-1919-4 D Discontinued by firm 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019422-001 DYNA-HEX 2 CHLORHEXIDINE GLUCONATE 2% SOLUTION / TOPICAL RLD, RS 1985-12-17
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DYNA-HEX 2 CHLORHEXIDINE GLUCONATE Xttrium Laboratories, Inc. 6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63 2026-04-27 Warnings Exact identifier Bactoshield CHG CHLORHEXIDINE GLUCONATE 2% Xttrium Laboratories, Inc. edfd2be7-b14b-7bd1-e053-2a95a90aa668 2025-12-08 Warnings Exact identifier foaming hand wash CHLORHEXIDINE GLUCONATE Medline Industries, LP 9b926809-65e9-4e5b-e053-2995a90add10 2025-09-08 Warnings Exact identifier Provon Antimicrobial Foam Handwash CHLORHEXIDINE GLUCONATE 2% Xttrium Laboratories, Inc. 46dd136c-d569-0450-e054-00144ff8d46c 2025-04-30 Warnings Exact identifier DYNA-HEX 2 CHLORHEXIDINE GLUCONATE Xttrium Laboratories, Inc. 6e5f9616-ddf5-19c4-e053-2991aa0a372a 2025-04-30 Warnings Exact identifier Dyna-Hex 2 CHLORHEXIDINE GLUCONATE 2% Xttrium Laboratories, Inc. 0c808ebd-1bf7-175d-e063-6294a90ae7df 2025-04-30 Warnings Exact identifier Purell Antimicrobial Foam CHLORHEXIDINE GLUCONATE 2% SOLUTION GOJO Industries, Inc. 6c7e63c2-428b-2be2-e053-2a91aa0a6af3 2024-12-21 Warnings Exact identifier Provon Antimicrobial Foam Handwash CHLORHEXIDINE GLUCONATE 2% Gojo Industries, Inc. 365c3ac6-6c1f-594b-e054-00144ff88e88 2022-12-20 Warnings Exact identifier Bactoshield CHG Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE SC Johnson Professional USA, Inc. 46084e90-6ffa-4e1a-a8ff-1c1b1484fe88 2022-11-28 Warnings Exact identifier Dyna-Hex 2 CHLORHEXIDINE GLUCONATE 2% Xttrium Laboratories, Inc. 36e6abcb-d792-3ef4-e054-00144ff8d46c 2020-10-13 Warnings Exact identifier Provon Antimicrobial Foam Handwash CHLORHEXIDINE GLUCONATE 2% Gojo Industries, Inc. 36803a5b-3075-5d5b-e054-00144ff8d46c 2019-06-19 Warnings Exact identifier Antimicrobial Skin Cleanser CHLORHEXIDINE GLUCONATE 2% SOLUTION Gojo Industries, Inc. 759beac3-6fc8-40c6-e053-2a91aa0aab57 2019-06-18 Warnings Exact identifier Purell Antimicrobial Foam CHLORHEXIDINE GLUCONATE 2% SOLUTION GOJO Industries, Inc. 6e0f3d2f-7834-68a0-e053-2991aa0ab453 2019-06-18 Warnings Exact identifier Antimicrobial Foam Handwash CHLORHEXIDINE GLUCONATE 2% SOLUTION GOJO Industries, Inc. 743021cd-38c3-3825-e053-2a91aa0aa7f2 2018-08-24 Warnings Exact identifier Antiseptic Foam Handwash CHLORHEXIDINE GLUCONATE 2% SOLUTION GOJO Industries, Inc. 74317b4d-3fbf-6fd5-e053-2a91aa0ab90f 2018-08-24 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORHEXIDINE GLUCONATE ACTIVE INGREDIENT MOR84MUD8E APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.] 6 CHLORHEXIDINE ACTIVE MOIETY R4KO0DY52L APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.] 6 COCO DIETHANOLAMIDE INACTIVE INGREDIENT 92005F972D APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.] 6 HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) INACTIVE INGREDIENT S38J6RZN16 APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.] 6 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.] 6 LAURAMINE OXIDE INACTIVE INGREDIENT 4F6FC4MI8W APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION (CHLORHEXIDINE GLUCONATE) SOLUTION [APLICARE, INC.] 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52380-1919-4 52380191904 118 mL in 1 BOTTLE (52380-1919-4) 118 ml 1998-09-01 2021-07-01 No No Current