Dakins Full

Product NDC: 0436-0946
11-digit product format: 004360946
Labeler code: 0436
Product ID: 0436-0946_4b0ae3e4-c66a-bbac-e063-6294a90a9ce8
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Hypochlorite
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Century Pharmaceuticals, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1983-12-08
Substance: SODIUM HYPOCHLORITE
Active strength: 5 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0436-0946-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0436-0946-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0436-0946-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0436-0946-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0436-0946-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0436-0946-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0436-0946-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0436-0946-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0436-0946-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0436-0946-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0436-0946-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0436-0946-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0436-0946-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0436-0946-16	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0436-0946-16	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0436-0946-16	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0436-0946-16	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0436-0946-16	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0436-0946-16	`8dfbde2a14a4…`	`c9ff85d89658…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dakins Full
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM HYPOCHLORITE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
DY38VHM5OD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313049	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
3d72b72c-2949-4eb6-b64c-6c4aef0eddd9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0436-0946-16	2021-01-29	C162847	48780-1	ba0f9c33-5775-a910-e053-dadaa90a0b85	Dakin's Full Strength (Sodium Hypochlorite 0.5%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0436-0946-16	Dakins Full	473 mL in 1 BOTTLE	SOLUTION	473		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0436-0946-16	ML - Milliliter	0436-0946	6d7a7124-a04a-458e-bc28-9ad8636dfd62	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Hypochlorite	ACTIVE INGREDIENT	DY38VHM5OD	DAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]	5
HYPOCHLOROUS ACID	ACTIVE MOIETY	712K4CDC10	DAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]	5
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	DAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0436-0946	DAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20190208_3d72b72c-2949-4eb6-b64c-6c4aef0eddd9.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dakins Full	SODIUM HYPOCHLORITE	Century Pharmaceuticals, Inc.	3d72b72c-2949-4eb6-b64c-6c4aef0eddd9	2026-02-17	Warnings	Exact identifier ndc (product): 0436-0946

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DY38VHM5OD	SODIUM HYPOCHLORITE	7681-52-9	SODIUM HYPOCHLORITE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313049	sodium hypochlorite 0.5 % Topical Solution	PSN	3d72b72c-2949-4eb6-b64c-6c4aef0eddd9	7
313049	sodium hypochlorite 5 MG/ML Topical Solution	SCD	3d72b72c-2949-4eb6-b64c-6c4aef0eddd9	7
313049	Dakin's full strength 0.5 % Topical Solution	SY	3d72b72c-2949-4eb6-b64c-6c4aef0eddd9	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0436-0946-16	00436094616	473 mL in 1 BOTTLE (0436-0946-16)	473 ml	2006-05-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dakin's Full Strength (Sodium Hypochlorite 0.5%)	Century Pharmaceuticals, Inc.	2026-02-17	HUMAN OTC DRUG LABEL	7