Silphen

Product NDC: 54838-154
11-digit product format: 548380154
Labeler code: 54838
Product ID: 54838-154_55ba2a3d-ba0d-4f50-88aa-ee45b5ea5592
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Lannett Company, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1993-12-03
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 13 mg/5mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54838-154		D	Discontinued by firm	2026-10-12
excluded package	package	54838-154	54838-154-40	D	Discontinued by firm	2026-10-12
excluded package	package	54838-154	54838-154-70	D	Discontinued by firm	2026-10-12
excluded package	package	54838-154	54838-154-80	D	Discontinued by firm	2026-10-12

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	54838-154-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54838-154-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54838-154-40	`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	54838-154-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54838-154-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54838-154-40	`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	54838-154-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54838-154-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54838-154-40	`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	54838-154-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54838-154-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54838-154-40	`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	54838-154-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54838-154-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54838-154-40	`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	54838-154-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54838-154-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54838-154-40	`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	54838-154-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54838-154-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54838-154-40	`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	54838-154-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54838-154-70	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54838-154-40	`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	54838-154-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54838-154-70	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54838-154-40	`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	54838-154-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54838-154-70	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54838-154-40	`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	54838-154-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54838-154-70	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54838-154-40	`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	54838-154-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54838-154-70	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54838-154-40	`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
54838-154-40	ML - Milliliter	54838-154	ed86f289-0a96-4b13-9dae-292558931232	1	2012-07-24
54838-154-70	ML - Milliliter	54838-154	9f75ada0-f789-499c-9840-9a75cdcb6db3	1	2012-07-24
54838-154-80	ML - Milliliter	54838-154	f105fa71-2350-4759-9e59-64189cd52cc5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diphenhydramine hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
Alcohol	INACTIVE INGREDIENT	3K9958V90M	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
ammonium chloride	INACTIVE INGREDIENT	01Q9PC255D	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
D&C red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
menthol	INACTIVE INGREDIENT	L7T10EIP3A	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
sucrose	INACTIVE INGREDIENT	C151H8M554	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17
water	INACTIVE INGREDIENT	059QF0KO0R	SILPHEN (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICAL, INC]	17

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
54838-154-40	54838015440	118 mL in 1 BOTTLE, PLASTIC (54838-154-40)	118 ml	1993-12-03	0000-00-00	No	No	Current
54838-154-70	54838015470	237 mL in 1 BOTTLE, PLASTIC (54838-154-70)	237 ml	1993-12-03	0000-00-00	No	No	Current
54838-154-80	54838015480	473 mL in 1 BOTTLE, PLASTIC (54838-154-80)	473 ml	1993-12-03	0000-00-00	No	No	Current