Insomnia

Product NDC: 68428-021
11-digit product format: 684280021
Labeler code: 68428
Product ID: 68428-021_9a67a989-ec5d-4a26-e053-2a95a90a826d
Type: HUMAN OTC DRUG
Nonproprietary name: MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP
Dosage form: PELLET
Route: ORAL
Labeler: Washington Homeopathic Products
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2010-04-02
Marketing end: 0000-00-00
Substance: MATRICARIA RECUTITA; ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA TOP
Active strength: 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68428-021		I	Inactivated by FDA		2026-08-11
excluded package	package	68428-021	68428-021-14	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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68428-021-14	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68428-021-14	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68428-021-14	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68428-021-14	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68428-021-14	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68428-021-14	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68428-021-14	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68428-021-14	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68428-021-14	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68428-021-14	2025-01-30	C162847	48780-1	2cef2736-a649-d83d-e063-dadaa90ab31f	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68428-021-14	Insomnia	300 in 1 BOTTLE, PLASTIC	PELLET	300		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARABICA COFFEE BEAN	ACTIVE INGREDIENT	3SW678MX72	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
HYOSCYAMUS NIGER	ACTIVE INGREDIENT	4WRK2153H3	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
PASSIFLORA INCARNATA TOP	ACTIVE INGREDIENT	CLF5YFS11O	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
STRYCHNOS IGNATII SEED	ACTIVE INGREDIENT	1NM3M2487K	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
ARABICA COFFEE BEAN	ACTIVE MOIETY	3SW678MX72	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
HYOSCYAMUS NIGER	ACTIVE MOIETY	4WRK2153H3	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
PASSIFLORA INCARNATA TOP	ACTIVE MOIETY	CLF5YFS11O	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
STRYCHNOS IGNATII SEED	ACTIVE MOIETY	1NM3M2487K	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68428-021	INSOMNIA (MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]	4	Legacy NDC, 1 package rows	20191224_f787e5fb-2185-4bfe-a609-177f7f55263d.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
3SW678MX72	ARABICA COFFEE BEAN	ARABICA COFFEE BEAN
4WRK2153H3	HYOSCYAMUS NIGER	HYOSCYAMUS NIGER
1NM3M2487K	STRYCHNOS IGNATII SEED	STRYCHNOS IGNATII SEED

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68428-021-14	68428002114	300 PELLET in 1 BOTTLE, PLASTIC (68428-021-14)	300 pellet	2010-04-02	0000-00-00	No	No	Current