Sky Oral Rinse

Product NDC: 63739-052
11-digit product format: 637390052
Labeler code: 63739
Product ID: 63739-052_e99683de-d0a4-373b-e053-2a95a90ac808
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorhexidine Gluconate
Dosage form: RINSE
Route: ORAL
Labeler: McKesson
Application: ANDA077789
Marketing category: ANDA
Marketing start: 2020-12-01
Substance: CHLORHEXIDINE GLUCONATE
Active strength: 1.2 mg/mL
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 42.

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
A077789-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT		2009-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077789-001	AT

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077789-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2009-06-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077789-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077789-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077789-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077789-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077789-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077789-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077789-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077789-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077789-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077789-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077789-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077789-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077789-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077789-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077789-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077789-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077789-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077789-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077789-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077789-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077789-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077789-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077789-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077789-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077789-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077789-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077789-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077789-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077789-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077789-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077789-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077789-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077789-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077789-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077789-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077789-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077789-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077789-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077789-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077789-001	AT	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sky Oral Rinse
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORHEXIDINE GLUCONATE	1.2 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
834127	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b479c166-899b-0565-e053-2995a90a2094	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63739-052-57	Sky Oral Rinse	600 mL in 1 PACKAGE	RINSE	600	4
63739-052-69	Sky Oral Rinse	1500 mL in 1 PACKAGE	RINSE	1500	4
63739-052-74	Sky Oral Rinse	15 mL in 1 CUP, UNIT-DOSE	RINSE	15	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-052-57	ML - Milliliter	63739-052	43147a08-d329-40ac-bc94-ab40d696dd96	1	2021-03-02
63739-052-69	ML - Milliliter	63739-052	74bc761e-7cf4-4749-ae67-2690ee57fd21	1	2021-03-02
63739-052-74	ML - Milliliter	63739-052	cb0c6df0-309b-47da-9bd8-1b3d50eb92ea	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-052	SKY ORAL RINSE (CHLORHEXIDINE GLUCONATE) RINSE [MCKESSON]	4	Current NDC, Legacy NDC, 3 package rows	20220928_b479c166-899b-0565-e053-2995a90a2094.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Major Oral Rinse	0.12% CHLORHEXIDINE GLUCONATE	Cardinal Health 107, LLC	baad6ebb-ba44-4abe-8882-f2391d17d816	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Major Oral Rinse	0.12% CHLORHEXIDINE GLUCONATE	Cardinal Health 107, LLC	772889a1-fc68-4400-9612-6fa51d0b6878	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Henry Schein, Inc.	0829509a-1b9b-5d8a-e054-00144ff8d46c	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Major Pharmaceuticals	b48e69dc-0913-423f-e053-2a95a90a53df	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Benco Dental	21b03b2a-44ee-41c0-e054-00144ff8d46c	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3a4cfe-88e0-0a10-e054-00144ff88e88	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3a684f-5f72-347a-e054-00144ff8d46c	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Preferred Pharmaceuticals, Inc.	1c3401ef-6a7a-485e-ab7e-52420a36f4e2	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	Sage Products LLC	3c754532-d9a5-f876-00c4-05a4c9b21efa	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Medline Industries, LP	92eddf00-7e23-4d5b-b5cd-38af99ad9e56	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	REMEDYREPACK INC.	7e3862b9-3786-4cfe-bfad-c992a7038eca	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a2c3c98-4e4e-1c9b-e054-00144ff88e88	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Xttrium Laboratories, Inc.	4a2a6bb8-85b0-6c36-e054-00144ff8d46c	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	ATLANTIC BIOLOGICALS CORP.	ec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Atlantic Biologicals Corps.	b445d769-a9e3-f72a-fbab-d485457996d0	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
NUPRO Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Xttrium Laboratories, Inc.	4a3b87bc-d913-6c88-e054-00144ff8d46c	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE	Xttrium Laboratories, Inc.	4a2bd280-918d-0e26-e054-00144ff88e88	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	NuCare Pharmaceuticals,Inc.	56e5e687-b1b5-6b43-e054-00144ff88e88	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
NUPRO Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"	d9d25abd-c3b4-4713-91c7-538f98e8fb70	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789
Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	A-S Medication Solutions	b589dcb9-883a-4f80-8f66-7a6c2051bf2a	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077789 application number: ANDA077789

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MOR84MUD8E	CHLORHEXIDINE GLUCONATE	18472-51-0	CHLORHEXIDINE GLUCONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN	b479c166-899b-0565-e053-2995a90a2094	4
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	b479c166-899b-0565-e053-2995a90a2094	4
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	b479c166-899b-0565-e053-2995a90a2094	4
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	b479c166-899b-0565-e053-2995a90a2094	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-052-57	63739005257	600 mL in 1 PACKAGE (63739-052-57)	600 ml	2021-02-15	0000-00-00	No	No	Current
63739-052-69	63739005269	1500 mL in 1 PACKAGE (63739-052-69)	1500 ml	2021-02-15	0000-00-00	No	No	Current
63739-052-74	63739005274	15 mL in 1 CUP, UNIT-DOSE (63739-052-74)	15 ml	2021-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0.12% Sky Unit Dose Cup	McKesson \| Xttrium Laboratories, Inc	2022-09-26	HUMAN PRESCRIPTION DRUG LABEL	4