Aplicare Chlorhexidine Gluconate 2% Solution
- Product NDC
- 52380-1919
- Requested package NDC
- 52380-1919-4
- 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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 52380-1919 | 52380-1919-4 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| 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 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N019422-001 | DYNA-HEX 2 | 2% | SOLUTION / TOPICAL | RLD, RS | 1985-12-17 | a50c72e98297… |
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. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| 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 | 019422 NDA019422 |
| Bactoshield CHG | CHLORHEXIDINE GLUCONATE 2% | Xttrium Laboratories, Inc. | edfd2be7-b14b-7bd1-e053-2a95a90aa668 | 2025-12-08 | Warnings | 019422 NDA019422 |
| foaming hand wash | CHLORHEXIDINE GLUCONATE | Medline Industries, LP | 9b926809-65e9-4e5b-e053-2995a90add10 | 2025-09-08 | Warnings | 019422 NDA019422 |
| Provon Antimicrobial Foam Handwash | CHLORHEXIDINE GLUCONATE 2% | Xttrium Laboratories, Inc. | 46dd136c-d569-0450-e054-00144ff8d46c | 2025-04-30 | Warnings | 019422 NDA019422 |
| DYNA-HEX 2 | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 6e5f9616-ddf5-19c4-e053-2991aa0a372a | 2025-04-30 | Warnings | 019422 NDA019422 |
| Dyna-Hex 2 | CHLORHEXIDINE GLUCONATE 2% | Xttrium Laboratories, Inc. | 0c808ebd-1bf7-175d-e063-6294a90ae7df | 2025-04-30 | Warnings | 019422 NDA019422 |
| Purell Antimicrobial Foam | CHLORHEXIDINE GLUCONATE 2% SOLUTION | GOJO Industries, Inc. | 6c7e63c2-428b-2be2-e053-2a91aa0a6af3 | 2024-12-21 | Warnings | 019422 NDA019422 |
| Provon Antimicrobial Foam Handwash | CHLORHEXIDINE GLUCONATE 2% | Gojo Industries, Inc. | 365c3ac6-6c1f-594b-e054-00144ff88e88 | 2022-12-20 | Warnings | 019422 NDA019422 |
| Bactoshield CHG Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | SC Johnson Professional USA, Inc. | 46084e90-6ffa-4e1a-a8ff-1c1b1484fe88 | 2022-11-28 | Warnings | 019422 NDA019422 |
| Dyna-Hex 2 | CHLORHEXIDINE GLUCONATE 2% | Xttrium Laboratories, Inc. | 36e6abcb-d792-3ef4-e054-00144ff8d46c | 2020-10-13 | Warnings | 019422 NDA019422 |
| Provon Antimicrobial Foam Handwash | CHLORHEXIDINE GLUCONATE 2% | Gojo Industries, Inc. | 36803a5b-3075-5d5b-e054-00144ff8d46c | 2019-06-19 | Warnings | 019422 NDA019422 |
| Antimicrobial Skin Cleanser | CHLORHEXIDINE GLUCONATE 2% SOLUTION | Gojo Industries, Inc. | 759beac3-6fc8-40c6-e053-2a91aa0aab57 | 2019-06-18 | Warnings | 019422 NDA019422 |
| Purell Antimicrobial Foam | CHLORHEXIDINE GLUCONATE 2% SOLUTION | GOJO Industries, Inc. | 6e0f3d2f-7834-68a0-e053-2991aa0ab453 | 2019-06-18 | Warnings | 019422 NDA019422 |
| Antimicrobial Foam Handwash | CHLORHEXIDINE GLUCONATE 2% SOLUTION | GOJO Industries, Inc. | 743021cd-38c3-3825-e053-2a91aa0aa7f2 | 2018-08-24 | Warnings | 019422 NDA019422 |
| Antiseptic Foam Handwash | CHLORHEXIDINE GLUCONATE 2% SOLUTION | GOJO Industries, Inc. | 74317b4d-3fbf-6fd5-e053-2a91aa0ab90f | 2018-08-24 | Warnings | 019422 NDA019422 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52380-1919-4 | ML - Milliliter | 52380-1919 | 7311f8e4-f3f8-4c01-98e5-bfb52d140ddd | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
Packages#
| 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 |