Diphenhydramine Hydrochloride

Product NDC: 81033-003
11-digit product format: 810330003
Labeler code: 81033
Product ID: 81033-003_c4ed2f1f-20e9-7d01-e053-2a95a90ae1d5
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Kesin Pharma Corporation
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-09-16
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 3 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	81033-003		I	Inactivated by FDA	2026-10-05
excluded package	package	81033-003	81033-003-41	I	Inactivated by FDA	2026-10-05
excluded package	package	81033-003	81033-003-52	I	Inactivated by FDA	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 · 33 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	81033-003-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81033-003-41	`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	81033-003-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81033-003-41	`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	81033-003-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81033-003-41	`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	81033-003-52	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81033-003-41	`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	81033-003-52	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81033-003-41	`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	81033-003-52	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81033-003-41	`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	81033-003-52	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81033-003-41	`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	81033-003-52	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81033-003-41	`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	81033-003-52	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81033-003-41	`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	81033-003-52	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	81033-003-41	`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	81033-003-52	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	81033-003-41	`367a005e9d99…`	`383a685ebd0f…`

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
81033-003-41	2024-07-30	C162847	48780-1	1e7a6dab-189d-a2ce-e063-dadaa90aadf7	Diphenhydramine HCl 2.5mg/mL Unit Dose Cups, 12.5mg/5 mL, 25mg/10mL
81033-003-52	2024-07-30	C162847	48780-1	1e7a6dab-189d-a2ce-e063-dadaa90aadf7	Diphenhydramine HCl 2.5mg/mL Unit Dose Cups, 12.5mg/5 mL, 25mg/10mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81033-003-05	Diphenhydramine Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	LIQUID	5	2
81033-003-10	Diphenhydramine Hydrochloride	10 mL in 1 CUP, UNIT-DOSE	LIQUID	10	2
81033-003-40	Diphenhydramine Hydrochloride	40 in 1 CARTON	LIQUID	40	2
81033-003-41	Diphenhydramine Hydrochloride	8 in 1 CASE	LIQUID	8	2
81033-003-50	Diphenhydramine Hydrochloride	50 in 1 CARTON	LIQUID	50	2
81033-003-52	Diphenhydramine Hydrochloride	8 in 1 CASE	LIQUID	8	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-003-05	ML - Milliliter	81033-003	f3701be5-9a5c-438f-b934-93806d66ebd4	1	2021-10-08
81033-003-10	ML - Milliliter	81033-003	5d902f8f-3bc7-4bea-914d-2933d9172d09	1	2021-10-08
81033-003-40	ML - Milliliter	81033-003	7ba3f437-e501-4726-9cbd-0f7dde860113	1	2021-10-08
81033-003-50	ML - Milliliter	81033-003	29f4b183-8acf-4b5d-9c82-ef7967038684	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81033-003	DIPHENHYDRAMINE HYDROCHLORIDE LIQUID [KESIN PHARMA CORPORATION]	2	Legacy NDC, 6 package rows	20230124_c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5.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	c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5	2
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5	2
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5	2
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5	2
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81033-003-05	81033000305	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
81033-003-10	81033000310	10 mL in 1 CUP, UNIT-DOSE	10 ml					Historical
81033-003-40	81033000340	40 in 1 CARTON						Historical
81033-003-41	81033000341	8 CARTON in 1 CASE (81033-003-41) > 40 CUP, UNIT-DOSE in 1 CARTON (81033-003-40) > 10 mL in 1 CUP, UNIT-DOSE (81033-003-10)	8 carton	2021-09-16	0000-00-00	No	No	Current
81033-003-50	81033000350	50 in 1 CARTON						Historical
81033-003-52	81033000352	8 CARTON in 1 CASE (81033-003-52) > 50 CUP, UNIT-DOSE in 1 CARTON (81033-003-50) > 5 mL in 1 CUP, UNIT-DOSE (81033-003-05)	8 carton	2021-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine HCl 2.5mg/mL Unit Dose Cups, 12.5mg/5 mL, 25mg/10mL	Kesin Pharma Corporation	2023-01-16	HUMAN OTC DRUG LABEL	2