Allergy

Product NDC: 37205-743
11-digit product format: 372050743
Labeler code: 37205
Product ID: 37205-743_c68bf779-a6a6-4dcb-b787-f19178e095d9
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health (Leader) 37205
Application: part336
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-10-30
Marketing end: 2019-12-31
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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	37205-743		D	Discontinued by firm	2026-10-16
excluded package	package	37205-743	37205-743-62	D	Discontinued by firm	2026-10-16
excluded package	package	37205-743	37205-743-78	D	Discontinued by firm	2026-10-16

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 · 36 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	37205-743-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37205-743-78	`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	37205-743-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37205-743-78	`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	37205-743-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37205-743-78	`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	37205-743-62	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37205-743-78	`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	37205-743-62	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37205-743-78	`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	37205-743-62	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37205-743-78	`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	37205-743-62	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37205-743-78	`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	37205-743-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37205-743-78	`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	37205-743-62	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37205-743-78	`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	37205-743-62	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37205-743-78	`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	37205-743-62	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37205-743-78	`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 package	package	37205-743-62	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37205-743-78	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-743-62	EA - Each	37205-743	3214f082-ad11-4deb-9b51-d363750cbe21	1	2013-05-02
37205-743-78	EA - Each	37205-743	56f8e839-28a0-48c5-ba0c-481d78c7952e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH (LEADER)]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Cardinal Health (Leader) 37205 \| P & L Development, LLC	2018-12-17	HUMAN OTC DRUG LABEL	3

Allergy

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#