Diphenhydramine HCL

Product NDC: 63187-866
11-digit product format: 631870866
Labeler code: 63187
Product ID: 63187-866_d27b1389-9287-4f39-91de-0d76a87f4e05
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-01-27
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/1

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
1020477	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
6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	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	SPL version
63187-866-10	Diphenhydramine HCL	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	5
63187-866-30	Diphenhydramine HCL	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	5
63187-866-60	Diphenhydramine HCL	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	5
63187-866-90	Diphenhydramine HCL	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-866-30	EA - Each	63187-866	fc05308c-f8cc-4834-8e27-c6d7bc05127c	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-866	DIPHENHYDRAMINE HCL CAPSULE [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 4 package rows	20240201_6e91b9c3-57e8-488b-ac70-d863cdf9d6e8.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 125 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health	LEVMETAMFETAMINE	Topco Associates LLC	8f995561-759a-4837-a82a-640417a6f889	2024-12-20	Warnings	Exact identifier application number: M012
Childrens Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores, Inc.	50a0eaa5-fa73-4d84-86fc-3546c85cf353	2024-12-20	Warnings	Exact identifier application number: M012
Equate Childrens Multi symptom Cold Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler	LEVMETAMFETAMINE NASAL DECONGESTANT	C.D.M.A., Inc.	904b7e21-cce5-4b96-afc1-b36f532f98ac	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Equaline	LEVMETAMFETAMINE	Supervalu Inc.	44f72f34-d0b8-421f-b240-86286de874cf	2024-12-20	Warnings	Exact identifier application number: M012
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

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
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	5
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	5
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-866-10	63187086610	10 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-10)	10 capsule	2020-07-10	0000-00-00	No	No	Current
63187-866-30	63187086630	30 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-30)	30 capsule	2017-06-01	0000-00-00	No	No	Current
63187-866-60	63187086660	60 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-60)	60 capsule	2017-06-01	0000-00-00	No	No	Current
63187-866-90	63187086690	90 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-90)	90 capsule	2017-06-01	0000-00-00	No	No	Current