Diphenhydramine HCl Oral Solution

Product NDC: 84415-013
11-digit product format: 844150013
Labeler code: 84415
Product ID: 84415-013_2bd97cb8-2b08-aa8d-e063-6394a90ad19d
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl Oral
Dosage form: SOLUTION
Route: ORAL
Labeler: Everpharm LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-16
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/10mL
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 Oral Solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/10mL

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
d7aaf874-69ac-49cf-93be-6d4a38b9a557	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
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84415-013-01	Diphenhydramine HCl Oral Solution	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10		1
84415-013-01	Diphenhydramine HCl Oral Solution	100 in 1 BOX, UNIT-DOSE	SOLUTION	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
84415-013-01	ML - Milliliter	84415-013	4a6ea4c8-4ad2-4c47-9a02-1ef93f62841e	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84415-013	DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [EVERPHARM LLC]	1	Current NDC, 2 package rows	20250119_d7aaf874-69ac-49cf-93be-6d4a38b9a557.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 96 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TexaClear Pain and Chest Congestion Relief	CHOLINE SALICYLATE,GUAIFENESIN	GM Pharmaceuticals, INC	672bc78a-2c71-4135-b64a-2b8c40ac688c	2025-10-13	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	Rejoice International Corp.	33d1fbf3-d33c-58b9-e063-6294a90ae098	2025-10-13	Warnings	Exact identifier application number: M012
Nitetime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	47f03174-6e91-4529-bbfa-ce58aa7b7d79	2025-10-13	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	db81e32b-0cad-400b-8479-a3b51de92b12	2025-10-10	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852b77ae-a5ac-3ead-e053-2a91aa0a54bd	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	8503c956-42a5-7684-e053-2991aa0adb27	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852ceea2-d6a1-6de2-e053-2a91aa0ad50d	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852d5f01-9289-5515-e053-2a91aa0acf32	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Diabetic Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	85183b38-ce2a-0e0e-e053-2991aa0a336f	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	8518fd91-981e-de78-e053-2a91aa0afcb2	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	852c8cd6-271f-0fa8-e053-2991aa0ab179	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	85065cf3-386d-22d5-e053-2a91aa0a72da	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8b2c847-25e9-8714-e053-2995a90a73ce	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852c5a57-7ee4-3c5c-e053-2a91aa0a1433	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c5027f-9701-fb07-e053-2a95a90a6029	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8c052d8-fb9f-09f2-e053-2a95a90a37af	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c53c14-ba82-2c68-e053-2a95a90a9894	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Severe Sinus	OXYMETAZOLINE HCL	Gil Pharmaceutical Corp	ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c08532-1169-6603-e053-2a95a90a3484	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c59e6d-c11c-2664-e053-2a95a90a8333	2025-10-09	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	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84415-013-01	84415001301	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-013-01) / 10 mL in 1 CUP, UNIT-DOSE	2025-01-16	No	No	Current