NDC 81033-003-05 - Diphenhydramine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 81033-003
Requested NDC: 81033-003-05
Package NDCs from labels: 81033-003-05, 81033-003-50, 81033-003-52, 81033-003-10, 81033-003-40, 81033-003-41
Manufacturer: Kesin Pharma Corporation
Effective date: 2023-01-16
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Diphenhydramine Hydrochloride - Kesin Pharma Corporation	Kesin Pharma Corporation	2023-01-16	HUMAN OTC DRUG LABEL

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 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

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 55 of 80 · 1,595 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adult Allergy Relief	CALMCO ALLERGY RELIEF	CalmCo	08288825-0f38-b6a3-e063-6394a90aa358	2024-12-07	Warnings	Exact identifier unii: TC2D6JAD40
CalmCo Sleep Aid Gummy Bite	DIPHENHYDRAMINE HCL	CalmCo LLC	0c534cbd-40e6-8af0-e063-6394a90a5605	2024-12-07	Warnings	Exact identifier unii: TC2D6JAD40
Somnapure Clinical Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Force Factor Brands LLC	063517c0-bcb1-46dd-85f1-bbb2f24274ef	2024-12-06	Warnings	Exact identifier unii: TC2D6JAD40
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	3ef6d155-b95b-4b30-87a8-8ed811b1520f	2024-12-03	Warnings	Exact identifier unii: TC2D6JAD40
good sense allergy	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	2861b801-e778-822d-e063-6394a90aa1a8	2024-12-03	Warnings	Exact identifier rxcui: 1049906 unii: TC2D6JAD40
Burts Bees Rapid Rescue Cold Sore Treatment	CAMPHOR, GLYCERIN	Burts Bees	9f89735d-205f-4d3e-a1e1-ecc96284fe98	2024-12-03	Warnings	Exact identifier unii: PDC6A3C0OX
Bite and Itch	DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	Weeks & Leo Co., Inc.	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	2024-12-03	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	76724432-ff3c-404f-ba1f-5af68e3ab8c4	2024-12-02	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	c280cf02-ebb2-4847-a66d-d02aff3ea0c9	2024-12-02	Warnings	Exact identifier unii: TC2D6JAD40
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	409b5fcd-5880-4dda-85d8-26aeceb4f8ab	2024-12-02	Warnings	Exact identifier unii: TC2D6JAD40
NOTTS - Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	e6754f62-e3b2-773f-e053-2a95a90ad36a	2024-12-02	Warnings	Exact identifier unii: TC2D6JAD40
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	53b15e75-9efd-4b4b-834b-6e9f12c60108	2024-12-02	Warnings	Exact identifier unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc.	6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f	2024-12-02	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	CVS Pharmacy, Inc.	6dd802ec-fc26-3913-e053-2a91aa0ad05d	2024-12-02	Warnings	Exact identifier unii: TC2D6JAD40
Extra Strength Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	INGLES MARKETS, INC.	27fd288e-c07a-617f-e063-6394a90a17a4	2024-11-28	Warnings	Exact identifier unii: TC2D6JAD40
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Geri-Care Pharmaceutical Corp	ac8a14ac-7023-1e23-e053-2995a90aea3a	2024-11-28	Warnings	Exact identifier unii: TC2D6JAD40
Childrens Benadryl DYE-FREE ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	2024-11-27	Warnings	Exact identifier rxcui: 1049906 unii: TC2D6JAD40
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	2024-11-27	Warnings	Exact identifier rxcui: 1049906 unii: TC2D6JAD40
Benadryl Original Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	920c50cb-9bdd-4a36-bb3d-c2559db73327	2024-11-26	Warnings	Exact identifier unii: TC2D6JAD40
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%	PURIFIED WATER 98.3%	Acme United Corporation	9248ee71-2d47-620d-e053-2995a90af5c8	2024-11-26	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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