FDA.reportPublic FDA data

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-37941163-379-34DDiscontinued by firm2026-10-20

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e4eb1eb-5b55-4531-94d2-998425ec80edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41163-379-262024-01-30C16284748780-11030e365-282a-111a-e063-dadaa90a10e2SuperValu Inc. Allergy Drug Facts
41163-379-342024-01-30C16284748780-11030e365-282a-111a-e063-dadaa90a10e2SuperValu Inc. Allergy Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-379-26equaline allergy118 mL in 1 BOTTLESOLUTION1188
41163-379-26equaline allergy1 in 1 CARTONSOLUTION18
41163-379-34equaline allergy1 in 1 CARTONSOLUTION18
41163-379-34equaline allergy236 mL in 1 BOTTLESOLUTION2368

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-379-26ML - Milliliter41163-379a8cb4e05-521a-4416-b4d1-446af7e12ce912013-02-13
41163-379-34ML - Milliliter41163-37969910dc3-a5df-4323-9429-f5a988a7bc1212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULREQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
SORBITOLINACTIVE INGREDIENT506T60A25REQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-379EQUALINE ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI]7Current NDC, Legacy NDC, 4 package rows20241013_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 25 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC9aca1a68-893c-4770-8a48-d5d6780582532026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
application number: M012
Goodmeds Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.37533188-8c91-428b-a796-c5afd9e4959f2026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
application number: M012
Delsym Nighttime CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC27f9d2db-38ce-41d2-8f1a-0eb1716002742026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCb37b786e-0cce-419d-94ed-3b64a1eb12012026-05-27WarningsExact identifier
application number: M012
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsExact identifier
application number: M012
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
application number: M012
Air PowerGUAIFENESINSchwabe North America, Inc5cdefc7a-6242-4681-88a3-04422a1d48d32026-05-27WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.adb658c8-db8d-4db6-80c8-e0f2de88a2de2026-05-27WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyc71427d4-707f-411f-8bd4-133517a9992b2026-05-26WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCVS PHARMACY, INC643e929d-9e62-4260-91ee-e88a184dd7cd2026-05-26WarningsExact identifier
application number: M012
TopCare Day Time Nite Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCc00ff684-acaf-4fbe-bc74-7e48751b927d2026-05-26WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Nasal Decongestant PEPHENYLEPHRINECabinet Health P.B.C.4e75da23-35f2-431c-92cb-c2c4cb3f09f12026-05-26WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy13492631-d5de-4562-a201-664f7d3591de2026-05-26WarningsExact identifier
application number: M012
Sinufrin DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc52a2e5f9-e0a2-02f7-e063-6294a90a3ae92026-05-25WarningsExact identifier
application number: M012
Cough Suppressant AdultDEXTROMETHORPHAN HYDROBROMIDERugby Laboratories47b713bd-4c1e-f44a-e063-6294a90a63d32026-05-25WarningsExact identifier
application number: M012
ClorReliefCHLORPHENIRAMINE MALEATEFERRER MEDICAL INNOVATIONS LLCdb729011-f72f-5911-e053-2a95a90a68bf2026-05-22WarningsExact identifier
application number: M012
Childrens Dye Free Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporation74ff4f0d-7952-4b74-b1b2-5a2beab91f7c2026-05-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN8e4eb1eb-5b55-4531-94d2-998425ec80ed8
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD8e4eb1eb-5b55-4531-94d2-998425ec80ed8
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY8e4eb1eb-5b55-4531-94d2-998425ec80ed8
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY8e4eb1eb-5b55-4531-94d2-998425ec80ed8
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY8e4eb1eb-5b55-4531-94d2-998425ec80ed8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-379-26411630379261 BOTTLE in 1 CARTON (41163-379-26) / 118 mL in 1 BOTTLE1 bottle2004-08-170000-00-00NoNoCurrent
41163-379-34411630379341 BOTTLE in 1 CARTON (41163-379-34) > 236 mL in 1 BOTTLE1 bottle2004-08-100000-00-00NoNoCurrent