Home NDC 16571-111 CHLORHEXIDINE GLUCONATE
Product NDC 16571-111
11-digit product format 165710111
Labeler code 16571
Product ID 16571-111_32cca440-c887-49ab-9c52-0b43fdf87b78
Type HUMAN OTC DRUG
Nonproprietary name chlorhexidine gluconate
Dosage form SOLUTION
Route TOPICAL
Labeler Rising Pharma Holdings, Inc.
Application NDA019258
Marketing category NDA
Marketing start 2023-07-26
Substance CHLORHEXIDINE GLUCONATE
Active strength 40 mg/mL
Pharmacologic classes Decreased Cell Wall Integrity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N019258-001 CIDA-STAT CHLORHEXIDINE GLUCONATE 2% SOLUTION / TOPICAL 1986-07-22 N019258-002 CHG SCRUB CHLORHEXIDINE GLUCONATE 4% SOLUTION / TOPICAL 1986-07-22
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 · 86 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 2026-09-14 22:38:34 2026-08 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019258-001 CIDA-STAT 2% SOLUTION / TOPICAL 1986-07-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019258-002 CHG SCRUB 4% SOLUTION / TOPICAL 1986-07-22 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CHLORHEXIDINE GLUCONATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORHEXIDINE GLUCONATE 40 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 211365 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 16571-111-12 CHLORHEXIDINE GLUCONATE 118 mL in 1 BOTTLE SOLUTION 118 2 16571-111-24 CHLORHEXIDINE GLUCONATE 237 mL in 1 BOTTLE SOLUTION 237 2 16571-111-48 CHLORHEXIDINE GLUCONATE 473 mL in 1 BOTTLE SOLUTION 473 2 16571-111-95 CHLORHEXIDINE GLUCONATE 946 mL in 1 BOTTLE SOLUTION 946 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-111 CHLORHEXIDINE GLUCONATE SOLUTION [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 4 package rows 20230830_d53a01eb-7213-4f19-b74f-acbf0fd54418.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 2 of 2 · 23 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Scrub, Scrub-Stat, Foam Safe, Micro-Guard CHLORHEXIDINE GLUCONATE AVA, Inc. 9dc69556-aebe-1270-e053-2a95a90a69a9 2022-12-26 Warnings Exact identifier application applno (NDA): 019258 application number: NDA019258 Scrub, Scrub-Stat, Foam Safe, Micro-Guard CHLORHEXIDINE GLUCONATE AVA, Inc. 9dc6d545-f831-9692-e053-2995a90adec5 2022-12-26 Warnings Exact identifier application applno (NDA): 019258 application number: NDA019258 Scrub, Scrub-Stat, Foam Safe, Micro-Guard CHLORHEXIDINE GLUCONATE AVA, Inc. 9dc60323-ed7c-199a-e053-2995a90a74b8 2022-12-26 Warnings Exact identifier application applno (NDA): 019258 application number: NDA019258
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 16571-111-12 16571011112 118 mL in 1 BOTTLE (16571-111-12) 118 ml 2023-07-26 No No Current 16571-111-24 16571011124 237 mL in 1 BOTTLE (16571-111-24) 237 ml 2023-07-26 No No Current 16571-111-48 16571011148 473 mL in 1 BOTTLE (16571-111-48) 473 ml 2023-07-26 No No Current 16571-111-95 16571011195 946 mL in 1 BOTTLE (16571-111-95) 946 ml 2023-07-26 No No Current