Diphenhydramine HCL

Product NDC: 66424-020
11-digit product format: 664240020
Labeler code: 66424
Product ID: 66424-020_2ba32ed3-96ca-2dd9-e063-6294a90a8d81
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: 25 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	66424-020-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66424-020-10	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	66424-020-10	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66424-020-01	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	66424-020-10	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66424-020-01	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	66424-020-10	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66424-020-01	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	66424-020-10	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66424-020-01	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	66424-020-10	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66424-020-01	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	66424-020-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66424-020-01	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	66424-020-01	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	66424-020-10	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	25 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
1049909	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
6a520986-1004-4ee6-9a47-1dfd90bb1b2c	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
66424-020-01	2023-06-13	Drug Facts
66424-020-10	2023-06-13	Drug Facts
66424-020-01	2020-01-31	Drug Facts
66424-020-10	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66424-020-01	Diphenhydramine HCL	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		3
66424-020-10	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
66424-020-01	EA - Each	66424-020	62be7459-d627-4d56-af74-b18dfb1581dc	1	2012-07-24
66424-020-10	EA - Each	66424-020	cc145bd4-6e21-4bfe-a7b2-2ffe0528742b	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 HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, 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 [BLENHEIM PHARMACAL, 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 [BLENHEIM PHARMACAL, 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 [BLENHEIM PHARMACAL, 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
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, 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
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	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 [PHYSICIANS TOTAL CARE, 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
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, 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
66424-020	DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250115_6a520986-1004-4ee6-9a47-1dfd90bb1b2c.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 113 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	40a6a7e3-6ec9-4005-9406-9d5b044b3c21	2025-06-16	Warnings	Exact identifier application number: M012
Daytime Nighttime Sinus Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Target Corporation	23f50b88-52c3-2029-e063-6394a90ac73e	2025-06-14	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Berries Flavor 25ct	PECTIN	Dollar General Corporation	c53c19a9-5984-4b08-ae46-a53dc8bb7d74	2025-06-13	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry Flavor 25ct	PECTIN	Dollar General Corporation	d82034ca-b7fd-48c8-ab4a-8e1e56418324	2025-06-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Belleview Biosciences	1db57d86-39f0-f8ca-e063-6394a90a6397	2025-06-12	Warnings	Exact identifier application number: M012
TARGET Cold and Cough and Nighttime Value Pack	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL,	TARGET CORPORATION	ce536313-7265-405c-88b7-f45e62781da5	2025-06-11	Warnings	Exact identifier application number: M012
Capron Max	DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE	Capital Pharmaceutical, LLC	3756812b-f128-8946-e063-6294a90a59ba	2025-06-11	Warnings	Exact identifier application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	60311ca3-8544-417e-aa29-e9f65c6692ba	2025-06-11	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	e65d2815-6932-123c-e053-2a95a90a2cf9	2025-06-10	Warnings	Exact identifier application number: M012
Cold Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	0cc66c6c-db26-4bb2-a97d-c4106210d70c	2025-06-10	Warnings	Exact identifier application number: M012
Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	75a9c736-bc7e-4b7f-84ea-9474a37508ec	2025-06-10	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	KJD Pharma Private Limited	8877bb8d-479f-4968-8033-5c269d449a46	2025-06-10	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Morning Star OTC	f4ff84b3-bb0c-4900-8ba4-6d1b90394782	2025-06-09	Warnings	Exact identifier application number: M012
Equate Kids Daytime Dex Cough Gels	DEXTROMETHORPHAN	Walmart	37269cd6-1528-9879-e063-6394a90a2b54	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	NUVICARE LLC	bdc35570-c8df-4797-a13e-7f2479ec42b7	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime and NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	f5764925-c586-40e4-8252-24d92389af01	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare NightTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	2a29f0ed-d86b-4787-84e0-f7a8c5e7581f	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime and NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	7fa8e4ad-95cb-4905-90db-d53b3bc87c41	2025-06-09	Warnings	Exact identifier application number: M012
Vaporizing Steam Liquid	MEDICATED COUGH SUPPRESSANT	NeilMed Pharmaceuticals Inc.	36cf6218-adb8-9d8b-e063-6394a90a49a0	2025-06-05	Warnings	Exact identifier application number: M012
Geri-Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	7e2fb43c-a7f1-4c1d-a700-7c6510999c03	2025-06-05	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
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	5767f546-a751-4583-a8b7-971175c27ef0	8
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	a5809774-ed52-4f54-b48e-888631e0223d	8
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	a5809774-ed52-4f54-b48e-888631e0223d	8
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	5767f546-a751-4583-a8b7-971175c27ef0	8
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	59aeb692-2f79-45aa-8e6a-dab77cd3b2f9	5
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	3dbdf67f-766b-12ee-e054-00144ff8d46c	5
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	59aeb692-2f79-45aa-8e6a-dab77cd3b2f9	5
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	3dbdf67f-766b-12ee-e054-00144ff8d46c	5
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	5411544e-3c2d-4e42-e054-00144ff8d46c	4
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	5411544e-3c2d-4e42-e054-00144ff8d46c	4
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	5943d975-77e4-4cbd-b2d9-d699052fe82a	3
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	6a520986-1004-4ee6-9a47-1dfd90bb1b2c	3
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	5943d975-77e4-4cbd-b2d9-d699052fe82a	3
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	6a520986-1004-4ee6-9a47-1dfd90bb1b2c	3
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	7d6268c7-b2a9-1bbf-e053-2a91aa0a5d32	2
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	117fead9-699d-57ae-e054-00144ff88e88	2
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	7d6268c7-b2a9-1bbf-e053-2a91aa0a5d32	2
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	117fead9-699d-57ae-e054-00144ff88e88	2
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	2b9b13b5-b530-4359-b094-1708c7a8e6d5	1
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	17df154b-af18-43ab-ae62-332b33454e4c	1
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	c46e1443-dffe-47a9-bc9a-acbe3a8b0b41	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	2b9b13b5-b530-4359-b094-1708c7a8e6d5	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	17df154b-af18-43ab-ae62-332b33454e4c	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
66424-020-01	66424002001	100 CAPSULE in 1 BOTTLE, PLASTIC (66424-020-01)	100 capsule	2010-01-27	No	No	Current
66424-020-10	66424002010	1000 CAPSULE in 1 BOTTLE, PLASTIC (66424-020-10)	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	A-S Medication Solutions	2026-01-09	HUMAN OTC DRUG LABEL	8
Drug Facts	A-S Medication Solutions	2026-01-09	HUMAN OTC DRUG LABEL	8
Drug Facts	Bryant Ranch Prepack	2025-03-28	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. \| NuCarePharmaceuticals, Inc.	2024-07-10	HUMAN OTC DRUG LABEL	4
Drug Facts	Proficient Rx LP	2024-01-01	HUMAN OTC DRUG LABEL	3
Drug Facts	NuCare Pharmaceuticals, Inc.	2022-08-29	HUMAN OTC DRUG LABEL	5
Drug Facts	A-S Medication Solutions	2021-10-26	HUMAN OTC DRUG LABEL	1
Drug Facts	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-07-27	HUMAN OTC DRUG LABEL	2
Drug Facts	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN OTC DRUG LABEL	3
Drug Facts	REMEDYREPACK INC.	2019-03-05	HUMAN OTC DRUG LABEL	3
Drug Facts	medsource pharmaceuticals \| Pharbest Pharmaceuticals, Inc.	2018-12-19	HUMAN OTC DRUG LABEL	2
Drug Facts	St. Mary’s Medical Park Pharmacy \| Pharbest Pharmaceuticals, Inc.	2018-11-12	HUMAN OTC DRUG LABEL	3
Drug Facts	Blenheim Pharmacal, Inc.	2015-03-17	HUMAN OTC DRUG LABEL	2
Drug Facts	Physicians Total Care, Inc.	2012-06-05	HUMAN OTC DRUG LABEL	1
Diphenhydramine Drug Facts	Rebel Distributors Corp	2011-02-15	HUMAN OTC DRUG LABEL	1