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: 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	41163-379	41163-379-34	D	Discontinued by firm		2026-08-17

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: equaline allergy
Listing expiration: 2026-12-31

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 1 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	610accad-2f8b-4605-9357-a58e6e18d417	2026-08-15	Warnings	Exact identifier application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY	27820bce-6638-4f17-ac66-62b02b76bec3	2026-08-14	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE	CVS PHARMACY, INC.	004e104b-d6ff-48d5-8685-cd1bff45399a	2026-08-14	Warnings	Exact identifier application number: M012
CHILDRENS DIMETAPP COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	7babf4f6-ca0a-44a7-b1ea-d60e20d36f15	2026-08-14	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM and Overnight Cold and Flu	DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL	CVS	75520b77-d40b-4f43-b92a-7a3eba5b493f	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	bb24c298-1d00-4378-8de3-b4056220fa75	2026-08-14	Warnings	Exact identifier application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS Pharmacy,Inc.	6cb1d08b-e544-4084-b9ed-1e0d99a709c8	2026-08-14	Warnings, Adverse reactions	Exact identifier application number: M012
Theraflu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	932a3d40-9b52-4e91-bc61-6fd506f2d9e6	2026-08-14	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy,Inc.	91063edd-1e7e-41e9-8412-b14ef3749018	2026-08-14	Warnings	Exact identifier application number: M012
CVS Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS PHARMACY, INC.	f4020c08-29f6-4609-834e-191ce6885130	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Cough, Flu Plus Sore Throat Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	95203001-7ca6-4513-83a3-9ef17855bc0f	2026-08-14	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	81d26e9c-b713-4fb3-b0a5-68526bad230e	2026-08-14	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	e9d0b6f9-e9f3-431c-9f34-4d63108282a1	2026-08-13	Warnings	Exact identifier application number: M012
daytime nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Amazon.com Services LLC	9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e	2026-08-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	1e3c81b0-05de-4c4a-8579-f301f14626b3	2026-08-13	Warnings	Exact identifier application number: M012
Tussin DM Daytime Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d59f6c64-8311-48ba-90d1-8000b04bfcda	2026-08-13	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5578e6-7e67-c467-e063-6294a90a6e0b	2026-08-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f95220c5-e55c-4271-a267-d004ad2447bf	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	569b8efa-8458-49f7-a665-6b7016a10505	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY DYE FREE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7	2026-08-12	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