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 126 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Tussnex	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	19e9678d-ac34-4af8-a80f-d08fce0a5f0e	2024-12-19	Warnings	Exact identifier application number: M012
Vaporising Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	New Pride Corp	f66476d5-036b-0b1c-e053-2a95a90a0a07	2024-12-19	Warnings	Exact identifier application number: M012
Chest Rub Vaporizing Action	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Singhfam Corporation	c6ea663a-9c4f-4d1a-a937-002806a8530a	2024-12-19	Warnings	Exact identifier application number: M012
ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION	CAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUS	Singhfam Corporation	f1e4caee-b50e-a0a6-e053-2a95a90aadce	2024-12-19	Warnings	Exact identifier application number: M012
Leader Vapor Steam camphor (synthetic)	CAMPHOR (SYNTHETIC)	LEADER/Cardinal Health 110, Inc.	ae580e6c-2efd-c788-e053-2995a90a3360	2024-12-19	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Strategic Sourcing Service, LLC	0b6689db-ea34-9a06-e063-6394a90abaf7	2024-12-19	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Jell Pharmaceuticals Pvt Ltd.	d80b9cc1-55f5-76d5-e053-2995a90aa967	2024-12-19	Warnings	Exact identifier application number: M012
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Home Smart Products	acab200e-48bd-69e1-e053-2995a90afde0	2024-12-19	Warnings	Exact identifier application number: M012
Halls MENTHO-LYPTUS	MENTHOL	Mondelez Global LLC	ff21cf0e-9811-4819-bdfc-17a950e9b114	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Cold, Flu and Sore Throat	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	7bddce11-c227-4d95-94c1-6f41ecd7285b	2024-12-19	Warnings	Exact identifier application number: M012
Childrens Tussnex Multi-symptom cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	9028676e-d725-4afe-aa14-72235825aa17	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Cold and Sinus	ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	04c6bb6a-d2f8-4322-afba-e240e8090176	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Severe cough and congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	387df403-7803-4031-915e-8de9b103a162	2024-12-19	Warnings	Exact identifier application number: M012
Maximum strength Tussnex FM DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Guardian Drug Company	0bae53e3-9661-4bc6-9fcc-da7fa131b034	2024-12-19	Warnings	Exact identifier application number: M012
Vicks Vaposteam Lavender	CAMPHOR, (-)-	Kaz USA, Inc	03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa9	2024-12-19	Warnings	Exact identifier application number: M012
Refenesen Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Reese Pharmaceutical Co	6046dc50-f162-4e2d-aa3c-7d27efad477d	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief PE PE	GUAIFENESIN/PHENYLEPHRINE	Strategic Sourcing Services LLC	f94ae469-4c79-4ce9-9a3d-3bdc645be6d9	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Chain Drug Marketing Association	1c33a01f-1186-4a19-b639-a9cd49245220	2024-12-18	Warnings	Exact identifier application number: M012
HealthMart Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c	2024-12-18	Warnings	Exact identifier application number: M012
DG Health Immediate Release Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	f60a9d1b-7a63-43d3-b843-e1f31cf78873	2024-12-18	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