equaline allergy

Product NDC: 41163-379
11-digit product format: 411630379
Labeler code: 41163
Product ID: 41163-379_5b8d0a9d-b61c-4ec0-b0b4-fc09cfc69277
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-08-10
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/5mL
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

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	41163-379	41163-379-34	D	Discontinued by firm		2026-10-23

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 · 12 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: equaline allergy
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

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
1049906	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
8e4eb1eb-5b55-4531-94d2-998425ec80ed	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
41163-379-26	2024-01-30	C162847	48780-1	1030e365-282a-111a-e063-dadaa90a10e2	SuperValu Inc. Allergy Drug Facts
41163-379-34	2024-01-30	C162847	48780-1	1030e365-282a-111a-e063-dadaa90a10e2	SuperValu Inc. Allergy Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41163-379-26	equaline allergy	118 mL in 1 BOTTLE	SOLUTION	118	8
41163-379-26	equaline allergy	1 in 1 CARTON	SOLUTION	1	8
41163-379-34	equaline allergy	1 in 1 CARTON	SOLUTION	1	8
41163-379-34	equaline allergy	236 mL in 1 BOTTLE	SOLUTION	236	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-379-26	ML - Milliliter	41163-379	a8cb4e05-521a-4416-b4d1-446af7e12ce9	1	2013-02-13
41163-379-34	ML - Milliliter	41163-379	69910dc3-a5df-4323-9429-f5a988a7bc12	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-379	EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI]	7	Current NDC, Legacy NDC, 4 package rows	20241013_8e4eb1eb-5b55-4531-94d2-998425ec80ed.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 74 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SF Honey Lemon Cough Drops	MENTHOL	The Kroger Co.	43281bd1-f8a7-02a4-e054-00144ff8d46c	2025-12-17	Warnings	Exact identifier application number: M012
Kroger Cherry Cough Drops	MENTHOL	Kroger	a2e1d1f5-9b19-1704-e053-2a95a90abb51	2025-12-17	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Major Pharmaceuticals	a9958b7d-7060-422b-a098-c1925c246081	2025-12-17	Warnings	Exact identifier application number: M012
Childrens Mucus Relief Cough Cherry Liquid	DEXTROMETHORPHAN HBR, GUAIFENSIN	Topco Associates	3170748e-b09f-4c07-9927-df43771166c5	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe	2025-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e70d0784-53bc-4910-aade-3c9ad6e36441	2025-12-16	Warnings	Exact identifier application number: M012
Pain and Sinus	ACETAMINOPHEN AND PHENYLEPHRINE	JHK Inc dba American Safety & First Aid	88f86f5a-cc2b-4c75-b7a4-f2021922280b	2025-12-16	Warnings	Exact identifier application number: M012
Severe Congestion and Cough, Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	b75af815-9bd4-4a7a-bc68-f42f4af50699	2025-12-16	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fe5fd29e-7f81-4633-8c3b-010d68abe701	2025-12-16	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	e0a62fa1-9f8a-4770-b28b-1f4f02a762e0	2025-12-16	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	8c4b59b8-dfab-4f4a-9966-f07b026a758a	2025-12-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	df866cf6-0526-4e61-ac9b-245b57dd5df6	2025-12-16	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	c89200b6-4adb-452e-b931-07f631dad641	2025-12-16	Warnings	Exact identifier application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	45fa9159-d74c-063a-e063-6294a90a3ed0	2025-12-15	Warnings	Exact identifier application number: M012
SudoGest Nasal Decongestant	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	5229f4b2-a194-46f8-a0bc-4510fbe52075	2025-12-15	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f2b2467f-2d9b-4742-b90a-95975c3b694f	2025-12-13	Warnings	Exact identifier application number: M012
Menthol Cough Drop	MENTHOL	HEB	39178eb7-ada9-30bf-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
SF Menthol Cough Drop	MENTHOL	HEB	3a443179-b7a6-3242-e054-00144ff8d46c	2025-12-13	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	HEB	39bd0ca1-348f-0ce1-e054-00144ff88e88	2025-12-13	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	HEB	766236e2-3302-2232-e053-2991aa0af503	2025-12-13	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
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	8e4eb1eb-5b55-4531-94d2-998425ec80ed	8
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	8e4eb1eb-5b55-4531-94d2-998425ec80ed	8
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	8e4eb1eb-5b55-4531-94d2-998425ec80ed	8
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	8e4eb1eb-5b55-4531-94d2-998425ec80ed	8
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	8e4eb1eb-5b55-4531-94d2-998425ec80ed	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-379-26	41163037926	1 BOTTLE in 1 CARTON (41163-379-26) / 118 mL in 1 BOTTLE	1 bottle	2004-08-17	0000-00-00	No	No	Current
41163-379-34	41163037934	1 BOTTLE in 1 CARTON (41163-379-34) > 236 mL in 1 BOTTLE	1 bottle	2004-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SuperValu Inc. Allergy Drug Facts	United Natural Foods, Inc. dba UNFI	2025-11-13	HUMAN OTC DRUG LABEL	8