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 177 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCUS RELIEF	GUAIFENESIN	KROGER COMPANY	813b1db2-a177-77c6-e053-2a91aa0ac73b	2023-01-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	DEXTROMETHORPHAN HBR/GUAIFENESIN	KROGER COMPANY	813baf42-edb0-33a9-e053-2a91aa0a8599	2023-01-17	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H-E-B	db19b8c7-0334-0664-e053-2a95a90ad61f	2023-01-14	Warnings	Exact identifier application number: M012
Nightime	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	H-E-B	db44560b-da02-74c9-e053-2a95a90af0b6	2023-01-13	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	dbf5656b-9105-871b-e053-2995a90a4941	2023-01-03	Warnings	Exact identifier application number: M012
DAYTIME-NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	KROGER	a2508699-08c0-4a22-e053-2a95a90a8a6d	2022-11-02	Warnings	Exact identifier application number: M012
GUAIFENESIN	GUAIFENESIN	PAI Holdings, LLC dba PAI Pharma	c2e53fb5-2798-47c8-9285-d1077d46e629	2022-06-14	Warnings	Exact identifier application number: M012
Mucus Relief DM	MUCUS RELIEF DM	TopCo Associates, LLC	71674a9b-89ed-43d1-aadb-b9311fdfbdf9	2022-06-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Combo Pack	DAYTIME NIGHTTIME COLD AND FLU	Allegiant Health	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	2022-05-19	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Good Sense	26a199bf-57e5-4f36-b40c-83a1187e4870	2022-05-18	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Allegiant Health	731f8608-ad5b-491e-a4d4-2bb0c423fed5	2022-05-18	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b3c229a4-c772-70fb-e053-2a95a90a72db	2022-03-11	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Good Sense	f88e2654-8e97-4cf6-9c36-01aeb51a9102	2021-11-30	Warnings	Exact identifier application number: M012
Cold Medicine	COLD MEDICINE	Allegiant Health	443fbc44-2c33-4316-ad31-dcc5a5aa8f52	2021-11-23	Warnings	Exact identifier application number: M012
Decongestant PE Non Drowsy	PHENYLEPHRINE HCL	Allegiant Health	7a3098b4-381c-4f32-97a7-87b53fd64428	2021-06-16	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN 400MG	Good Sense	e7c68746-7ec0-46cf-b4a3-174fab819b5e	2021-05-05	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN 400MG	TopCo Associates, LLC	7d91c6ab-d161-42b9-b353-0aa8f59619f8	2021-01-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG	Allegiant Health	bed5f9dc-45ea-4e90-86c6-86599b6f3861	2020-11-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN	Allegiant Health	b97126d7-847d-483e-b3d1-e2b61ab1743f	2020-11-11	Warnings	Exact identifier application number: M012
Cold and Allergy	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Allegiant Health	7af63769-fa56-4f1f-a2ad-5b4c108c8e4f	2019-12-12	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