Nightime Sleep Aid

Product NDC: 58805-006
11-digit product format: 588050006
Labeler code: 58805
Product ID: 58805-006_8a592765-a0be-417d-9ca5-ba530235a986
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Agile Pharmachem
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-03-31
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58805-006		I	Inactivated by FDA	2026-08-17
excluded product	product	58805-006		I	Inactivated by FDA	2026-08-17
excluded package	package	58805-006	58805-006-02	I	Inactivated by FDA	2026-08-17
excluded package	package	58805-006	58805-006-00	I	Inactivated by FDA	2026-08-17
excluded package	package	58805-006	58805-006-01	I	Inactivated by FDA	2026-08-17

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 2 · 105 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58805-006-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58805-006-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58805-006-02	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58805-006-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58805-006-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58805-006-02	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58805-006-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58805-006-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58805-006-02	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58805-006-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58805-006-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58805-006-02	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58805-006-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58805-006-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58805-006-02	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58805-006-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58805-006-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58805-006-02	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58805-006-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58805-006-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58805-006-02	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58805-006-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58805-006-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58805-006-02	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58805-006-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58805-006-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58805-006-02	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58805-006-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58805-006-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58805-006-02	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58805-006-00	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58805-006-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58805-006-02	`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 product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58805-006-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58805-006-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58805-006-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58805-006-00	2020-01-31	C162847	48780-1	9d75b9d0-de85-f424-e053-dadaa90a57ce	DIPHENHYDRAMINE HCl 50mg, USP
58805-006-01	2020-01-31	C162847	48780-1	9d75b9d0-de85-f424-e053-dadaa90a57ce	DIPHENHYDRAMINE HCl 50mg, USP
58805-006-02	2020-01-31	C162847	48780-1	9d75b9d0-d5be-f424-e053-dadaa90a57ce	DIPHENHYDRAMINE HCl 50mg, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58805-006-00	Nightime Sleep Aid	1 in 1 BAG	CAPSULE, LIQUID FILLED	1	2
58805-006-00	Nightime Sleep Aid	750 in 1 BOX	CAPSULE, LIQUID FILLED	750	2
58805-006-01	Nightime Sleep Aid	30 in 1 BAG	CAPSULE, LIQUID FILLED	30	2
58805-006-01	Nightime Sleep Aid	750 in 1 BOX	CAPSULE, LIQUID FILLED	750	2
58805-006-02	Nightime Sleep Aid	750 in 1 BAG	CAPSULE, LIQUID FILLED	750	2
58805-006-02	Nightime Sleep Aid	48 in 1 BOX	CAPSULE, LIQUID FILLED	48	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
POLYVINYL ACETATE PHTHALATE	INACTIVE INGREDIENT	58QVG85GW3	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58805-006	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2	Legacy NDC, 4 package rows	20150331_114b71f9-36b1-4372-805e-65cbb61f2925.zip
58805-006	NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]	2	Legacy NDC, 2 package rows	20180521_3f12bd24-8265-44a0-9112-92c026c8e2fa.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
8GTS82S83M	DIPHENHYDRAMINE	58-73-1	Diphenhydramine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	114b71f9-36b1-4372-805e-65cbb61f2925	2
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	3f12bd24-8265-44a0-9112-92c026c8e2fa	2
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	114b71f9-36b1-4372-805e-65cbb61f2925	2
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	3f12bd24-8265-44a0-9112-92c026c8e2fa	2
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	114b71f9-36b1-4372-805e-65cbb61f2925	2
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	3f12bd24-8265-44a0-9112-92c026c8e2fa	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
58805-006-00	58805000600	1 in 1 BAG	Historical
58805-006-01	58805000601	30 in 1 BAG	Historical
58805-006-02	58805000602	750 in 1 BAG	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIPHENHYDRAMINE HCl 50mg, USP	Agile Pharmachem	2018-05-21	HUMAN OTC DRUG LABEL	2
DIPHENHYDRAMINE HCl 50mg, USP	Agile Pharmachem	2015-03-31	HUMAN OTC DRUG LABEL	2