Childrens Allergy

Product NDC: 66007-212
11-digit product format: 660070212
Labeler code: 66007
Product ID: 66007-212_557a995c-3fe4-411c-94ef-f6d4f1bd0a55
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Capricorn Pharma Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-09-29
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 13 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66007-212		I	Inactivated by FDA		2026-10-05
excluded package	package	66007-212	66007-212-02	I	Inactivated by FDA		2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66007-212-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66007-212-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66007-212-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66007-212-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66007-212-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66007-212-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66007-212-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66007-212-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66007-212-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66007-212-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66007-212-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66007-212-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66007-212-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66007-212-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66007-212-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66007-212-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66007-212-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66007-212-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66007-212-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66007-212-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66007-212-02	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66007-212-02	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66007-212-02	2019-10-29	C162847	48780-1	960f7f55-cd64-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66007-212-01	Childrens Allergy	6 in 1 BLISTER PACK	TABLET	6		1
66007-212-02	Childrens Allergy	3 in 1 CARTON	TABLET	3		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	INACTIVE INGREDIENT	U72Q2I8C85	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
ETHYLCELLULOSE	INACTIVE INGREDIENT	7Z8S9VYZ4B	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66007-212	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]	1	Legacy NDC, 2 package rows	20101012_327ccd2d-dcc6-4919-83d7-51d8920b7b01.zip

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
882504	diphenhydrAMINE HCl 12.5 MG Disintegrating Oral Tablet	PSN	327ccd2d-dcc6-4919-83d7-51d8920b7b01	1
882504	diphenhydramine hydrochloride 12.5 MG Disintegrating Oral Tablet	SCD	327ccd2d-dcc6-4919-83d7-51d8920b7b01	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66007-212-01	66007021201	6 in 1 BLISTER PACK	Historical
66007-212-02	66007021202	3 in 1 CARTON	Historical