Eclipse Topical Analgesic

Product NDC: 54723-669
Requested package NDC: 54723-669-03
11-digit product format: 547230669
Labeler code: 54723
Product ID: 54723-669_a3801b6f-fc54-4ad9-88c0-2dc968ab75cb
Type: HUMAN OTC DRUG
Nonproprietary name: Tetracaine HCL
Dosage form: CREAM
Route: TOPICAL
Labeler: Sambria Pharmaceuticals, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-02-01
Marketing end: 0000-00-00
Substance: TETRACAINE HYDROCHLORIDE
Active strength: 20 mg/1000mg
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54723-669	54723-669-03	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 · 20 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54723-669-03	2021-07-23	C162847	48780-1	c7ccaba7-2118-fd44-e053-dadaa90aa01b	Eclipse LL Topical Analgesic
54723-669-05	2021-07-23	C162847	48780-1	c7ccaba7-24cc-fd44-e053-dadaa90aa01b	Eclipse LL Topical Analgesic
54723-669-09	2021-07-23	C162847	48780-1	c7ccaba7-12cf-fd44-e053-dadaa90aa01b	Eclipse LL Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54723-669-05	Eclipse Topical AnalgesicLL	5 mg in 1 PACKET	CREAM	5	3
54723-669-03	Eclipse Topical AnalgesicLL	3000 mg in 1 PACKET	CREAM	3000	2
54723-669-09	Eclipse Topical AnalgesicLL	1500 mg in 1 PACKET	CREAM	1500	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54723-669	ECLIPSE TOPICAL ANALGESIC LL (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.]	3	Legacy NDC, 1 package rows	20191227_bb67a8d2-8799-4672-ac4a-a9124f1f543f.zip
54723-669	ECLIPSE TOPICAL ANALGESIC LL (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.]	2	Legacy NDC, 1 package rows	20191227_6e0e3594-0c69-495e-9972-13af2773c88d.zip
54723-669	ECLIPSE TOPICAL ANALGESIC LL (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.]	2	Legacy NDC, 1 package rows	20191227_be19e1aa-0dae-4534-8cff-2af13347e963.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5NF5D4OPCI	TETRACAINE HYDROCHLORIDE	136-47-0	TETRACAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1543158	tetracaine HCl 2 % Topical Cream	PSN	bb67a8d2-8799-4672-ac4a-a9124f1f543f	3
1543158	tetracaine hydrochloride 20 MG/ML Topical Cream	SCD	bb67a8d2-8799-4672-ac4a-a9124f1f543f	3
1543158	tetracaine HCl 2 % Topical Cream	SY	bb67a8d2-8799-4672-ac4a-a9124f1f543f	3
1543158	tetracaine HCl 2 % Topical Cream	PSN	6e0e3594-0c69-495e-9972-13af2773c88d	2
1543158	tetracaine HCl 2 % Topical Cream	PSN	be19e1aa-0dae-4534-8cff-2af13347e963	2
1543158	tetracaine hydrochloride 20 MG/ML Topical Cream	SCD	6e0e3594-0c69-495e-9972-13af2773c88d	2
1543158	tetracaine hydrochloride 20 MG/ML Topical Cream	SCD	be19e1aa-0dae-4534-8cff-2af13347e963	2
1543158	tetracaine HCl 2 % Topical Cream	SY	6e0e3594-0c69-495e-9972-13af2773c88d	2
1543158	tetracaine HCl 2 % Topical Cream	SY	be19e1aa-0dae-4534-8cff-2af13347e963	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54723-669-03	54723066903	3000 mg in 1 PACKET (54723-669-03)	3000 mg	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eclipse LL Topical Analgesic	Sambria Pharmaceuticals, Inc. \| A.I.G. Technologies, Inc. \| JP Packaging LLC	2018-08-06	HUMAN OTC DRUG LABEL	3
Eclipse LL Topical Analgesic	Sambria Pharmaceuticals, Inc. \| A.I.G. Technologies, Inc. \| JP Packaging LLC	2018-08-06	HUMAN OTC DRUG LABEL	2
Eclipse LL Topical Analgesic	Sambria Pharmaceuticals, Inc. \| A.I.G. Technologies, Inc. \| JP Packaging LLC	2018-08-06	HUMAN OTC DRUG LABEL	2