Allergy Medicine

Product NDC: 15127-283
11-digit product format: 151270283
Labeler code: 15127
Product ID: 15127-283_d4712f97-ea63-4b19-93bd-39be639b19c1
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: L&R Distributors, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1990-03-15
Marketing end: 2021-09-10
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	15127-283		D	Discontinued by firm	2026-10-05
excluded package	package	15127-283	15127-283-12	D	Discontinued by firm	2026-10-05
excluded package	package	15127-283	15127-283-24	D	Discontinued by firm	2026-10-05
excluded package	package	15127-283	15127-283-48	D	Discontinued by firm	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 · 48 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	15127-283-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15127-283-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15127-283-12	`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	15127-283-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15127-283-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15127-283-12	`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	15127-283-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	15127-283-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	15127-283-12	`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	15127-283-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	15127-283-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	15127-283-12	`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	15127-283-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	15127-283-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	15127-283-12	`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	15127-283-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	15127-283-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	15127-283-12	`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	15127-283-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15127-283-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15127-283-12	`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	15127-283-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15127-283-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15127-283-12	`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	15127-283-48	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	15127-283-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	15127-283-12	`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	15127-283-48	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	15127-283-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	15127-283-12	`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	15127-283-48	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	15127-283-24	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	15127-283-12	`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	15127-283-48	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	15127-283-24	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	15127-283-12	`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
15127-283-24	EA - Each	15127-283	c01fd97e-4c15-468e-bfb6-20272392116f	1	2012-07-24
15127-283-48	EA - Each	15127-283	5c8ac6bd-6b28-47c5-8baf-189a26faaac7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [STEPHEN L. LAFRANCE PHARMACY, INC.]	2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
15127-283-12	15127028312	100 CAPSULE in 1 BOTTLE, PLASTIC (15127-283-12)	100 capsule	1990-03-15	2021-09-10	No	No	Current
15127-283-24	15127028324	2 BLISTER PACK in 1 CARTON (15127-283-24) > 12 CAPSULE in 1 BLISTER PACK	2 blister pack	1990-03-15	2021-09-10	No	No	Current
15127-283-48	15127028348	4 BLISTER PACK in 1 CARTON (15127-283-48) > 12 CAPSULE in 1 BLISTER PACK	4 blister pack	1990-03-15	2021-09-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Select Brand 44-190-delisted	L&R Distributors, Inc. \| LNK International, Inc.	2018-10-13	HUMAN OTC DRUG LABEL	7