NAUS-EASE

Product NDC: 49467-104
11-digit product format: 494670104
Labeler code: 49467
Product ID: 49467-104_f93712d1-5843-440d-8eeb-edeed5a30e05
Type: HUMAN OTC DRUG
Nonproprietary name: MECLIZINE HYDROCHLORIDE
Dosage form: FILM, SOLUBLE
Route: ORAL
Labeler: Sunascen Therapeutics LLC
Application: part336
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-04-16
Marketing end: 0000-00-00
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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	49467-104		I	Inactivated by FDA	2026-10-05
excluded package	package	49467-104	49467-104-01	I	Inactivated by FDA	2026-10-05
excluded package	package	49467-104	49467-104-16	I	Inactivated by FDA	2026-10-05

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 · 33 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	49467-104-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49467-104-01	`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	49467-104-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49467-104-01	`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	49467-104-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49467-104-01	`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	49467-104-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49467-104-01	`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	49467-104-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49467-104-01	`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	49467-104-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49467-104-01	`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	49467-104-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49467-104-01	`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	49467-104-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49467-104-01	`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	49467-104-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49467-104-01	`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	49467-104-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49467-104-01	`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	49467-104-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49467-104-01	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49467-104-01	2024-07-30	NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information
49467-104-16	2024-07-30	NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information
49467-104-01	2024-01-30	NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information
49467-104-16	2024-01-30	NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information
49467-104-01	2023-02-09	NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information
49467-104-16	2023-02-09	NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information
49467-104-01	2023-01-30	NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information
49467-104-16	2023-01-30	NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49467-104-01	NAUS-EASE	8 in 1 CARTON	FILM, SOLUBLE	8	16
49467-104-01	NAUS-EASE	1 in 1 POUCH	FILM, SOLUBLE	1	16
49467-104-16	NAUS-EASE	1 in 1 POUCH	FILM, SOLUBLE	1	16
49467-104-16	NAUS-EASE	16 in 1 CARTON	FILM, SOLUBLE	16	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	7
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	7
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	7
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	7
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	7
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49467-104	NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC]	16	Legacy NDC, 4 package rows	20230211_45ed34ea-457f-4d7e-8d2f-2c3ff5054a87.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDP7W44CIO	MECLIZINE HYDROCHLORIDE	31884-77-2	MECLIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996062	meclizine HCl 25 MG Oral Film	PSN	45ed34ea-457f-4d7e-8d2f-2c3ff5054a87	16
996062	meclizine hydrochloride 25 MG Oral Film	SCD	45ed34ea-457f-4d7e-8d2f-2c3ff5054a87	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49467-104-01	49467010401	8 POUCH in 1 CARTON (49467-104-01) > 1 FILM, SOLUBLE in 1 POUCH	8 pouch	2012-04-16	0000-00-00	No	No	Current
49467-104-16	49467010416	16 POUCH in 1 CARTON (49467-104-16) > 1 FILM, SOLUBLE in 1 POUCH	16 pouch	2012-04-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information	Sunascen Therapeutics LLC	2023-02-09	HUMAN OTC DRUG LABEL	16