Diphenhydramine HCl

Product NDC: 0121-0865
11-digit product format: 001210865
Labeler code: 0121
Product ID: 0121-0865_d56f4fe1-e90c-4e35-a488-12c93938a3dd
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-18
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
3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
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
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
0121-0865-00	Diphenhydramine HCl	10 in 1 CASE	SOLUTION	10	5
0121-0865-00	Diphenhydramine HCl	10 in 1 TRAY	SOLUTION	10	5
0121-0865-05	Diphenhydramine HCl	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	5
0121-0865-30	Diphenhydramine HCl	10 in 1 TRAY	SOLUTION	10	5
0121-0865-30	Diphenhydramine HCl	3 in 1 CASE	SOLUTION	3	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0865	DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	5	Current NDC, Legacy NDC, 5 package rows	20240911_3c3e0dc8-cddd-4f46-9b68-19bac00c07cc.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 146 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	b1ba8ade-3441-f243-e053-2995a90a1230	2024-10-21	Warnings	Exact identifier application number: M012
Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	b1ba22ac-c38d-a42e-e053-2995a90a6900	2024-10-21	Warnings	Exact identifier application number: M012
Diphenhydramine HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	25034563-6422-daf6-e063-6394a90af980	2024-10-21	Warnings	Exact identifier application number: M012
Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	198add5f-20b7-75b0-e063-6394a90a6bd4	2024-10-21	Warnings	Exact identifier application number: M012
Tukol Honey Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	dae33df8-2294-4242-a25b-2d89d1f63b23	2024-10-18	Warnings	Exact identifier application number: M012
sinus pressure and pain pe	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a7931e4c-8a5e-66e2-e053-2995a90af2a4	2024-10-18	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	570ea130-6a99-446e-9f97-14fc95809006	2024-10-18	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a14999e3-a9d9-0a1f-e053-2995a90af7b3	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a793000b-3ef9-5662-e053-2a95a90ad0da	2024-10-18	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime and Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	37455f86-ab21-472b-9e80-40324699f3ca	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3396a27-8643-71fa-e053-2a95a90a713d	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3397f69-3267-ca0b-e053-2995a90a7db5	2024-10-18	Warnings	Exact identifier application number: M012
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	747512a2-3b6d-496b-ab80-819060314163	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	9daf7f40-d9c5-4367-be41-894208358fc1	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	608e6808-29e4-40bc-8496-24c092681a1b	2024-10-18	Warnings	Exact identifier application number: M012
Cold Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	665db127-ee04-46c4-bff0-e0fe9950c3e2	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8	2024-10-18	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	604d7e53-4bfd-4cdd-aed2-b304ae82ce44	2024-10-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	4d93a703-c905-4fb3-b772-11c207065d4d	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	62c35320-87b5-46e2-9f6f-cb0882bdb52e	2024-10-17	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	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	5
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	5
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	5
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	5
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	5
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	1b591e27-b00b-41c8-9fe9-c633aba09134	2
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	1b591e27-b00b-41c8-9fe9-c633aba09134	2
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	1b591e27-b00b-41c8-9fe9-c633aba09134	2
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	1b591e27-b00b-41c8-9fe9-c633aba09134	2
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	1b591e27-b00b-41c8-9fe9-c633aba09134	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0865-00	00121086500	10 TRAY in 1 CASE (0121-0865-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)	10 tray	2020-06-18	0000-00-00	No	No	Current
0121-0865-05	00121086505	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
0121-0865-30	00121086530	3 TRAY in 1 CASE (0121-0865-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)	3 tray	2020-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenyhydramine HCl Oral Solution, USP	Major Pharmaceuticals	2025-08-01	HUMAN OTC DRUG LABEL	2
Diphenydramine HCl Oral Solution, USP	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-01-05	HUMAN OTC DRUG LABEL	5