Diphenhydramine HCL

Product NDC: 84447-103
11-digit product format: 844470103
Labeler code: 84447
Product ID: 84447-103_3765beab-e853-b34f-e063-6394a90ac9d5
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: SOLUTION
Route: ORAL
Labeler: Belleview Biosciences
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-20
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Diphenhydramine HCL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049906	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1db57d86-39f0-f8ca-e063-6394a90a6397	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84447-103-01	Diphenhydramine HCL	200000 mL in 1 DRUM	SOLUTION	200000	2
84447-103-04	Diphenhydramine HCL	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118	2
84447-103-16	Diphenhydramine HCL	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
84447-103-16	ML - Milliliter	84447-103	3fbeb6a1-3362-4f18-b499-87b41d9d205c	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84447-103	DIPHENHYDRAMINE HCL SOLUTION [BELLEVIEW BIOSCIENCES]	1	Current NDC, 3 package rows	20241109_1db57d86-39f0-f8ca-e063-6394a90a6397.zip

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 128 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Family Dollar Services Inc	8aee8108-a4e0-4956-8e37-6b3b1c5dc683	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Chest Congestion Relief	GUAIFENESIN	TOPCO ASSOCIATES LLC	b8339617-17ce-4ad7-af38-399ecc74d864	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	THE KROGER CO	976bfdcf-2110-486c-aa6e-cd2067334cdc	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	AmerisourceBergen Drug Corp	79cefd46-bd19-4a1d-9cb1-e85ff0f12494	2024-12-18	Warnings	Exact identifier application number: M012
Leader Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Cardinal Health	8397e1b9-e83e-4c6a-b858-1663c2365840	2024-12-18	Warnings	Exact identifier application number: M012
GNP Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	AmerisourceBergen Drug Corp	63932e68-b09d-4500-bc1d-cfb2c267df1c	2024-12-18	Warnings	Exact identifier application number: M012
Meijer Chest Congestion Relief	GUAIFENESIN	Meijer Distribution Inc.	ae02e0bd-d9e7-495f-b01f-b135b96934a0	2024-12-18	Warnings	Exact identifier application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PE	GUAIFENESIN/PHENYLEPHRINE	TOPCO ASSOCIATES LLC	b6c0362f-86ca-4f08-ba53-800c6df2c025	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Strategic Sourcing Services LLC	10cad9a7-1223-470c-9027-807891217d40	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Mucus Relief	GUAIFENESIN	THE KROGER CO	2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	41f88b43-3e0a-4650-b167-a72afe6177e8	2024-12-18	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Rugby Laboratories	5da36516-9f94-49cb-9421-0c310abcd116	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	THE KROGER CO	430c6604-93a7-4df6-a657-ba438aa61425	2024-12-18	Warnings	Exact identifier application number: M012
Discount Drugmart Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart, Inc	1ac281e1-22ea-42f8-98fe-ab3d5ff9a208	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	4c50233e-1dcb-427d-ba63-1538cf370061	2024-12-18	Warnings	Exact identifier application number: M012
Dollar General Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Dolgencorp, LLC	718f08d2-3757-4f3e-915e-3e4982ad090f	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AmerisourceBergen Drug Corp	e4610d53-4459-43a0-9351-f0ac8586df60	2024-12-18	Warnings	Exact identifier application number: M012
Always Save Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	Valu Merch	5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f6	2024-12-17	Warnings	Exact identifier application number: M012
Chestrub	CAMPHOR MENTHOL EUCALYPTUS OIL	Delta Brands Inc	8e6f731f-c16a-41b2-9786-0cab588cfc8e	2024-12-17	Warnings	Exact identifier application number: M012
Mentholatum Nighttime Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	5539ae74-9723-480d-b35f-0a6644bf54ad	2024-12-17	Warnings	Exact identifier application number: M012

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	1db57d86-39f0-f8ca-e063-6394a90a6397	2
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	1db57d86-39f0-f8ca-e063-6394a90a6397	2
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	1db57d86-39f0-f8ca-e063-6394a90a6397	2
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	1db57d86-39f0-f8ca-e063-6394a90a6397	2
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	1db57d86-39f0-f8ca-e063-6394a90a6397	2
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	2f871005-de4d-8b2a-e063-6394a90aa43a	1
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	2f871005-de4d-8b2a-e063-6394a90aa43a	1
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	2f871005-de4d-8b2a-e063-6394a90aa43a	1
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	2f871005-de4d-8b2a-e063-6394a90aa43a	1
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	2f871005-de4d-8b2a-e063-6394a90aa43a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84447-103-01	84447010301	200000 mL in 1 DRUM (84447-103-01)	200000 ml	2024-07-20	No	No	Current
84447-103-04	84447010304	118 mL in 1 BOTTLE, PLASTIC (84447-103-04)	118 ml	2024-07-20	No	No	Current
84447-103-16	84447010316	473 mL in 1 BOTTLE, PLASTIC (84447-103-16)	473 ml	2024-07-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine HCL	Belleview Biosciences	2025-06-12	HUMAN OTC DRUG LABEL	2
Diphenhydramine HCl Oral Solution, USP	Kesin Pharma Corporation	2025-03-04	HUMAN OTC DRUG LABEL	1