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		2026-10-16

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 118 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Ultra Concentrated Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELS	WALGREENS	2be0a699-e6ad-ef56-e063-6394a90aaca5	2025-04-03	Warnings	Exact identifier application number: M012
Cough and Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	44fb27d3-5125-4511-84d2-76555bc46e66	2025-04-03	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	31b8ad0a-3637-03db-e063-6394a90acdc3	2025-04-01	Warnings	Exact identifier application number: M012
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	31aa54d8-df8d-f1ae-e063-6294a90a9622	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Bryant Ranch Prepack	570a71eb-2d19-4c7b-8c00-e1524bfa3844	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	365c01b7-a197-4876-85fc-42204f787e3a	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	59aeb692-2f79-45aa-8e6a-dab77cd3b2f9	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Oncor Pharmaceuticals	06ecba97-c790-4672-a8c3-f9caf6272d26	2025-03-27	Warnings	Exact identifier application number: M012
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	87ebb4d9-78d7-1c87-e053-2a95a90adb7d	2025-03-27	Warnings	Exact identifier application number: M012
REVASOL CHILDRENS ALLERGY	DIPHENHYDRAMINE HCL	Rnv LLC	3143137f-ef42-5358-e063-6394a90a8ed1	2025-03-26	Warnings	Exact identifier application number: M012
Rompe Pecho SF FLU	DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Efficient Laboratories Inc	bc10695a-9664-4ce3-82bb-820da06129fa	2025-03-26	Warnings	Exact identifier application number: M012
SUPRESS-PE Pediatric	GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	a474171d-5c29-4a80-9d37-00613796211a	2025-03-26	Warnings	Exact identifier application number: M012
Guaifenesin DM	DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN	Innovida Pharmaeutique Corporation	dd3f806b-2470-4055-94e1-18adac811025	2025-03-25	Warnings	Exact identifier application number: M012
Foster and Thrive childrens cold cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	38b710e3-1d01-4ff4-a6b6-44936f277f49	2025-03-25	Warnings	Exact identifier application number: M012
Revasol Tussin DM Max with Honey	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Rnv LLC	30da9255-c93a-84d6-e063-6394a90a7c2a	2025-03-21	Warnings	Exact identifier application number: M012
REVASOL NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Rnv LLC	30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9	2025-03-21	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Meijer, Inc.	261a79b3-5704-76f2-e063-6394a90a5ac6	2025-03-20	Warnings	Exact identifier application number: M012
Rompe Tos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cc932d-b412-0710-e063-6394a90a87f6	2025-03-19	Warnings	Exact identifier application number: M012
Rompe Tos X Adults	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05abb2db-d22e-90b5-e063-6294a90ace3f	2025-03-19	Warnings	Exact identifier application number: M012
Sinus Head Congestion	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	30a07773-bd6f-b9f2-e063-6394a90ab8aa	2025-03-18	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