Diphenhydramine Oral Liquid

Product NDC: 53807-204
11-digit product format: 538070204
Labeler code: 53807
Product ID: 53807-204_e241709f-9874-407f-8de4-440c768d5b79
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Rij Pharmaceutical Corporation
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1999-03-16
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 13 mg/5mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53807-204		I	Inactivated by FDA	2026-10-15
excluded package	package	53807-204	53807-204-04	I	Inactivated by FDA	2026-10-15
excluded package	package	53807-204	53807-204-08	I	Inactivated by FDA	2026-10-15
excluded package	package	53807-204	53807-204-16	I	Inactivated by FDA	2026-10-15

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 · 84 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	53807-204-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-204-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-204-16	`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	53807-204-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-204-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-204-16	`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	53807-204-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-204-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-204-16	`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	53807-204-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-204-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-204-16	`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	53807-204-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-204-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-204-16	`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	53807-204-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-204-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-204-16	`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	53807-204-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-204-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-204-16	`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	53807-204-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-204-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-204-16	`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	53807-204-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53807-204-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53807-204-16	`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	53807-204-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53807-204-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53807-204-16	`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	53807-204-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53807-204-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53807-204-16	`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	53807-204-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53807-204-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53807-204-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53807-204-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53807-204-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53807-204-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53807-204-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53807-204-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53807-204-16	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53807-204-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53807-204-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53807-204-16	`1332a3947898…`	`d4bfe170f9cd…`

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53807-204-04	2020-01-31	C162847	48780-1	9d75b9d0-7d35-f424-e053-dadaa90a57ce	Drug Facts
53807-204-08	2020-01-31	C162847	48780-1	9d75b9d0-7d35-f424-e053-dadaa90a57ce	Drug Facts
53807-204-16	2020-01-31	C162847	48780-1	9d75b9d0-7d35-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53807-204-04	Diphenhydramine Oral Liquid	118 mL in 1 BOTTLE	LIQUID	118	2
53807-204-08	Diphenhydramine Oral Liquid	236 mL in 1 BOTTLE	LIQUID	236	2
53807-204-16	Diphenhydramine Oral Liquid	473 mL in 1 BOTTLE	LIQUID	473	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53807-204-04	ML - Milliliter	53807-204	3b81fe99-dfdb-447a-966c-6f1d15b68c5b	1	2014-06-03
53807-204-08	ML - Milliliter	53807-204	cb2375b2-0867-4db6-a2ef-0ce7bce07251	1	2014-06-03
53807-204-16	ML - Milliliter	53807-204	2f08347f-f1e5-4333-9297-86d671b0990b	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53807-204	DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 3 package rows	20180502_af5b9c99-03b8-4cf3-80d5-e484b36b6873.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	af5b9c99-03b8-4cf3-80d5-e484b36b6873	2
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	af5b9c99-03b8-4cf3-80d5-e484b36b6873	2
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	af5b9c99-03b8-4cf3-80d5-e484b36b6873	2
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	af5b9c99-03b8-4cf3-80d5-e484b36b6873	2
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	af5b9c99-03b8-4cf3-80d5-e484b36b6873	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53807-204-04	53807020404	118 mL in 1 BOTTLE	118 ml	Historical
53807-204-08	53807020408	236 mL in 1 BOTTLE	236 ml	Historical
53807-204-16	53807020416	473 mL in 1 BOTTLE	473 ml	Historical