Ambix First Aid

Product NDC: 10038-250
11-digit product format: 100380250
Labeler code: 10038
Product ID: 10038-250_9689b2a7-6fce-5b51-e053-2a95a90ae583
Type: HUMAN OTC DRUG
Nonproprietary name: DYCLONINE HYDROCHLORIDE and Phenol
Dosage form: CREAM
Route: TOPICAL
Labeler: Organics Corporation of America dba Ambix Laboratories
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-08-22
Marketing end: 0000-00-00
Substance: DYCLONINE HYDROCHLORIDE; PHENOL
Active strength: 0 g/g; g/g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10038-250		I	Inactivated by FDA	2026-08-11
excluded package	package	10038-250	10038-250-25	I	Inactivated by FDA	2026-08-11
excluded package	package	10038-250	10038-250-42	I	Inactivated by FDA	2026-08-11

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 · 54 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	10038-250-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10038-250-25	`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	10038-250-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10038-250-25	`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	10038-250-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10038-250-25	`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	10038-250-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10038-250-25	`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	10038-250-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10038-250-25	`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	10038-250-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10038-250-25	`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	10038-250-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10038-250-25	`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	10038-250-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10038-250-25	`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	10038-250-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10038-250-25	`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	10038-250-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10038-250-25	`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	10038-250-42	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10038-250-25	`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	10038-250-42	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10038-250-25	`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	10038-250-42	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10038-250-25	`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	10038-250-42	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10038-250-25	`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	10038-250-42	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10038-250-25	`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	10038-250-25	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10038-250-42	`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	10038-250-25	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10038-250-42	`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	10038-250-25	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10038-250-42	`bd6a592717d7…`	`303034d00443…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1da7d10e-498b-41dd-970f-0f5bd7432f39	Product name	1	20190228

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10038-250-25	2022-01-28	C162847	48780-1	d6a99b39-9f17-a426-e053-dadaa90af4c2	Ambix First Aid Antiseptic & Pain Relieving Cream
10038-250-42	2022-01-28	C162847	48780-1	d6a99b39-9f17-a426-e053-dadaa90af4c2	Ambix First Aid Antiseptic & Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10038-250-25	Ambix First Aid	1 in 1 BOX	CREAM	1	3
10038-250-25	Ambix First Aid	25 g in 1 TUBE	CREAM	25	3
10038-250-42	Ambix First Aid	42.5 g in 1 TUBE	CREAM	42.5	3
10038-250-42	Ambix First Aid	1 in 1 BOX	CREAM	1	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DYCLONINE HYDROCHLORIDE	ACTIVE INGREDIENT	ZEC193879Q	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
PHENOL	ACTIVE INGREDIENT	339NCG44TV	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
DYCLONINE	ACTIVE MOIETY	078A24Q30O	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
PHENOL	ACTIVE MOIETY	339NCG44TV	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10038-250	AMBIX FIRST AID (DYCLONINE HYDROCHLORIDE AND PHENOL) CREAM [ORGANICS CORPORATION OF AMERICA DBA AMBIX LABORATORIES]	3	Legacy NDC, 4 package rows	20191105_575989be-b9f2-4778-a92d-4ec8e1325c45.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZEC193879Q	DYCLONINE HYDROCHLORIDE	536-43-6	DYCLONINE HYDROCHLORIDE
339NCG44TV	PHENOL	108-95-2	PHENOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1435634	dyclonine HCl 0.5 % / phenol 0.5 % Topical Cream	PSN	575989be-b9f2-4778-a92d-4ec8e1325c45	3
1435634	dyclonine hydrochloride 5 MG/ML / phenol 5 MG/ML Topical Cream	SCD	575989be-b9f2-4778-a92d-4ec8e1325c45	3
1435634	dyclonine hydrochloride 0.5 % / phenol 0.5 % Topical Cream	SY	575989be-b9f2-4778-a92d-4ec8e1325c45	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10038-250-25	10038025025	1 TUBE in 1 BOX (10038-250-25) > 25 g in 1 TUBE	1 tube	2013-08-22	0000-00-00	No	No	Current
10038-250-42	10038025042	1 TUBE in 1 BOX (10038-250-42) > 42.5 g in 1 TUBE	1 tube	2013-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ambix First Aid Antiseptic & Pain Relieving Cream	Organics Corporation of America dba Ambix Laboratories \| Suite K Value Added Services LLC	2019-11-04	HUMAN OTC DRUG LABEL	3