Diphenhydramine HCL

Product NDC: 66424-021
11-digit product format: 664240021
Labeler code: 66424
Product ID: 66424-021_2ba30474-41ba-6c1a-e063-6394a90a9631
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: CAPSULE
Route: ORAL
Labeler: SDA Laboratories, Inc.
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66424-021-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66424-021-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66424-021-10	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66424-021-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66424-021-10	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66424-021-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66424-021-10	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66424-021-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66424-021-10	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66424-021-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66424-021-10	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66424-021-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66424-021-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66424-021-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66424-021-10	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66424-021-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
437e6a13-a4ff-4f98-8973-042f224ee85e	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
66424-021-01	2023-06-13	Drug Facts
66424-021-10	2023-06-13	Drug Facts
66424-021-01	2020-01-31	Drug Facts
66424-021-10	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66424-021-01	Diphenhydramine HCL	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		3
66424-021-10	Diphenhydramine HCL	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66424-021-01	EA - Each	66424-021	9776653f-7c63-4b8b-a643-b1ff64504064	1	2012-07-24
66424-021-10	EA - Each	66424-021	fa4dd348-3929-4217-a7fb-c7f312f780c8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66424-021	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250115_437e6a13-a4ff-4f98-8973-042f224ee85e.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 142 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good neighbor pharmacy adult tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	ced71993-f535-4e28-bc1d-3fcb7d86e9b7	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS Pharmacy	2f1dc8f8-79c5-4724-99aa-a55330ed9d5f	2024-11-08	Warnings	Exact identifier application number: M012
good sense day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	4ac6b64a-8214-4b03-8aa5-0d3199cf0b72	2024-11-08	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	1dd9afb6-9b58-4274-a557-900a0cb23524	2024-11-08	Warnings	Exact identifier application number: M012
DG health sinus severe	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	7abaa912-be8b-463c-8818-104e79b33539	2024-11-07	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Cold Plus Flu Multi-Action Day	ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	7d3266dc-879a-4d28-b8ea-74d238c3020a	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	2ddb86a8-e34c-4a03-a60a-d3fedaf90608	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ce43e5c2-fe96-4462-882c-d7479318b33d	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL SINUS PLUS HEADACHE DAY	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e608d214-cc46-4a24-ac85-1040e36e7403	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	2024-11-07	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.	Kenvue Brands LLC	f81d924e-10e9-0e9d-e053-6294a90a2ddf	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8b516736-86ac-47cb-a0ec-038d4c3a0020	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu plus Cough Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e85e5eb9-3ecf-4784-999e-111e38e306f5	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ef8a846d-4b29-4fd8-a683-fada04d0a2b9	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	9761c807-75a1-4498-a8c6-1f2b1c9ffde6	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Mucus Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	24ac94e8-b223-424e-bcd2-9c027c8ff9ed	2024-11-07	Warnings	Exact identifier application number: M012
Primatene	EPHEDRINE HYDROCHLORIDE	Foundation Consumer Brands	2170f081-c03f-47e8-bc63-4052c5e653fa	2024-11-07	Warnings	Exact identifier application number: M012
Rompe Pecho Max Multi Symptoms	ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN	EFFICIENT LABORATORIES INC	938e4e47-d2d9-4b0d-bf88-e9f41b501945	2024-11-07	Warnings	Exact identifier application number: M012
topcare sinus nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	ca1fefed-e9d7-430a-9da4-972b1a6fb786	2024-11-07	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	dd82a389-9ec5-4b3f-a9ea-1a56871ebd17	2024-11-07	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
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	3ac0beba-303d-404e-bfec-0cf8c0e8624d	12
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	3ac0beba-303d-404e-bfec-0cf8c0e8624d	12
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	3ac0beba-303d-404e-bfec-0cf8c0e8624d	12
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	3ac0beba-303d-404e-bfec-0cf8c0e8624d	12
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	3ac0beba-303d-404e-bfec-0cf8c0e8624d	12
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	c1873a4c-661f-4896-bcc0-f6d3a655de94	5
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	5
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	c1873a4c-661f-4896-bcc0-f6d3a655de94	5
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	5
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	c1873a4c-661f-4896-bcc0-f6d3a655de94	5
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	5
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	3dbdf020-ca17-1197-e054-00144ff8d46c	4
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	489645ad-d7da-5f52-e054-00144ff8d46c	4
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	489645ad-d7da-5f52-e054-00144ff8d46c	4
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	3dbdf020-ca17-1197-e054-00144ff8d46c	4
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	489645ad-d7da-5f52-e054-00144ff8d46c	4
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	3dbdf020-ca17-1197-e054-00144ff8d46c	4
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	437e6a13-a4ff-4f98-8973-042f224ee85e	3
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	437e6a13-a4ff-4f98-8973-042f224ee85e	3
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	437e6a13-a4ff-4f98-8973-042f224ee85e	3
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	c46e1443-dffe-47a9-bc9a-acbe3a8b0b41	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	c46e1443-dffe-47a9-bc9a-acbe3a8b0b41	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66424-021-01	66424002101	100 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-01)	100 capsule	2010-01-27	No	No	Current
66424-021-10	66424002110	1000 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-10)	1000 capsule	2010-01-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Preferred Pharmaceuticals, Inc.	2026-04-06	HUMAN OTC DRUG LABEL	12
Drug Facts	PD-Rx Pharmaceuticals, Inc.	2025-11-13	HUMAN OTC DRUG LABEL	5
Drug Facts	SDA Laboratories, Inc. \| Pharbest Pharmaceuticals, Inc.	2025-01-13	HUMAN OTC DRUG LABEL	3
Drug Facts	NuCare Pharmaceuticals, Inc.	2024-08-14	HUMAN OTC DRUG LABEL	4
Drug Facts	NuCare Pharmaceuticals, Inc.	2024-08-13	HUMAN OTC DRUG LABEL	4
Drug Facts	Proficient Rx LP	2024-01-01	HUMAN OTC DRUG LABEL	5
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