MYGRIN Nighttime

Product NDC: 49467-230
Requested package NDC: 49467-230-10
11-digit product format: 494670230
Labeler code: 49467
Product ID: 49467-230_49195084-4316-403d-9ce3-476c9ab21fc4
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Aspirin (NSAID), and Diphenhydramine Citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sunascen Therapeutics LLC
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-02-05
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE
Active strength: 250 mg/1; mg/1; mg/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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49467-230	49467-230-10	I	Inactivated by FDA		2026-11-06

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`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
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-30	MYGRIN ® Nighttime (Acetaminophen, Aspirin (NSAID), and Diphenhydramine Citrate), Caplets
2024-01-30	MYGRIN ® Nighttime (Acetaminophen, Aspirin (NSAID), and Diphenhydramine Citrate), Caplets
2023-02-09	MYGRIN ® Nighttime (Acetaminophen, Aspirin (NSAID), and Diphenhydramine Citrate), Caplets
2023-01-30	MYGRIN ® Nighttime (Acetaminophen, Aspirin (NSAID), and Diphenhydramine Citrate), Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49467-230-10	MYGRIN Nighttime	100 in 1 BOTTLE	TABLET, FILM COATED	100		6
49467-230-10	MYGRIN Nighttime	1 in 1 CARTON	TABLET, FILM COATED	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49467-230	MYGRIN NIGHTTIME (ACETAMINOPHEN, ASPIRIN (NSAID), AND DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [SUNASCEN THERAPEUTICS LLC]	6	Legacy NDC, 2 package rows	20230211_f03f43af-4db8-4b61-8371-6b6d8ce71712.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
4OD433S209	DIPHENHYDRAMINE CITRATE	88637-37-0	DIPHENHYDRAMINE CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1593110	acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet	PSN	f03f43af-4db8-4b61-8371-6b6d8ce71712	6
1593110	acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet	SCD	f03f43af-4db8-4b61-8371-6b6d8ce71712	6
1593110	APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet	SY	f03f43af-4db8-4b61-8371-6b6d8ce71712	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49467-230-10	49467023010	1 BOTTLE in 1 CARTON (49467-230-10) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2018-02-05	0000-00-00	No	No	Current