careone allergy relief

Product NDC: 41520-778
11-digit product format: 415200778
Labeler code: 41520
Product ID: 41520-778_703c7305-4a5a-4d22-ae35-db8657dccf8c
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: American Sales Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-09-21
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41520-778	41520-778-62	D	Discontinued by firm		2026-10-15

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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: careone allergy relief
Listing expiration: 2026-12-31

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
1049630	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
ed4038fc-ab39-4567-9961-2b390b91b126	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41520-778-62	2024-01-30	C162847	48780-1	1030e364-fda6-111a-e063-dadaa90a10e2	American Sales Company Allergy Relief Drug Facts
41520-778-78	2024-01-30	C162847	48780-1	1030e364-fda6-111a-e063-dadaa90a10e2	American Sales Company Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41520-778-62	careone allergy relief	24 in 1 CARTON	TABLET	24	5
41520-778-62	careone allergy relief	1 in 1 BLISTER PACK	TABLET	1	5
41520-778-78	careone allergy relief	1 in 1 CARTON	TABLET	1	5
41520-778-78	careone allergy relief	100 in 1 BOTTLE	TABLET	100	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-778	CAREONE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	5	Current NDC, Legacy NDC, 4 package rows	20240719_ed4038fc-ab39-4567-9961-2b390b91b126.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 66 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Premier Value	COUGH DROPS CHERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2de803-900d-02f4-e063-6394a90a84cc	2025-12-29	Warnings	Exact identifier application number: M012
QUALITY CHOICE	COUGH DROPS HONEY LEMON SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2307f3a7-f6e7-8a5d-e063-6394a90ab7eb	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2e8fbe-c1c3-79b1-e063-6394a90a4d73	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS HONEY LEMON	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2dfcc3-e599-3102-e063-6394a90ad54a	2025-12-29	Warnings	Exact identifier application number: M012
Premier Value	COUGH DROPS BLACK CHERRY SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2a2ead3c-b4d5-ee8f-e063-6294a90a3c39	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS CREAMY STRAWBERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f42644-045b-c4b3-e063-6294a90a48fd	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS VANILLA HONEY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f45499-bf14-03e4-e063-6394a90a535c	2025-12-29	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS BLACK CHERRY SUGAR FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f3ddcc-9d4e-f1b1-e063-6294a90ac86f	2025-12-29	Warnings	Exact identifier application number: M012
Menthol Flavor Cough Drop	MENTHOL FLAVOR COUGH DROP	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a5551-4989-d8fe-e063-6394a90aeabf	2025-12-29	Warnings	Exact identifier application number: M012
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f2acaa-2cc8-a999-e063-6294a90a15ce	2025-12-29	Warnings	Exact identifier application number: M012
Leader Throat Soothing Drops Creamy Strawberry	THROAT SOOTHING CREAMY STRAWBERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26a92ecc-6a9c-b569-e063-6394a90a8bcb	2025-12-29	Warnings	Exact identifier application number: M012
ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	a5ceab90-6885-4f3a-b001-97679e03c01b	2025-12-29	Warnings	Exact identifier application number: M012
Goodmeds Non-Drowsy Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE	Cabinet Health P.B.C.	32482083-3f51-41f4-8d20-bedf143e066d	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel EX	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	77c16288-68c4-476c-995f-86f505663270	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Llorens Pharmaceutical International Division, Inc.	fe457e6d-422d-496c-bcb9-33594f3c42ff	2025-12-29	Warnings	Exact identifier application number: M012
Tusnel Diabetic	DEXTROMETHORPHAN, GUAIFENESIN	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	66b3c094-809e-4d2c-bc15-46563de685cb	2025-12-29	Warnings	Exact identifier application number: M012
Fortify	MENTHOL	Natures Formulae Health Products Ltd.	781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd	2025-12-29	Warnings	Exact identifier application number: M012
Safetussin PM Nighttime Cough relief	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kramer Laboratories	33dd2245-9abd-4b32-ac76-0f45a54c0f33	2025-12-29	Warnings	Exact identifier application number: M012
Winco Foods Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	WinCo Foods, LLC	f54eb60d-c602-1272-e053-2995a90aa95a	2025-12-28	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	ad4d74a8-a762-4378-9016-f7c83421073e	2025-12-26	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
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	ed4038fc-ab39-4567-9961-2b390b91b126	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	ed4038fc-ab39-4567-9961-2b390b91b126	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-778-62	41520077862	24 BLISTER PACK in 1 CARTON (41520-778-62) > 1 TABLET in 1 BLISTER PACK	24 blister pack	2017-09-21	0000-00-00	No	No	Current
41520-778-78	41520077878	1 BOTTLE in 1 CARTON (41520-778-78) / 100 TABLET in 1 BOTTLE	1 bottle	2017-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Allergy Relief Drug Facts	American Sales Company	2024-07-17	HUMAN OTC DRUG LABEL	5