Equaline Night Time Sleep Aid

Product NDC
41163-186
11-digit product format
411630186
Labeler code
41163
Product ID
41163-186_170f5e02-1901-4dc2-ac6e-ea22036d2a5e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-28
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
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 packagepackage41163-18641163-186-30DDiscontinued by firm2026-10-15

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 · 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 Night Time Sleep Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

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
1248354Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d34ee3e-3d61-481e-98d6-acfa066e4247Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-186-30Equaline Night Time Sleep Aid177 mL in 1 BOTTLESOLUTION1776
41163-186-40Equaline Night Time Sleep Aid355 mL in 1 BOTTLESOLUTION3556

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-186-30ML - Milliliter41163-18691962e4e-abe5-404c-9dd1-2b81964b578f12017-11-06
41163-186-40ML - Milliliter41163-186a8330ffe-842d-4840-9992-dda627435ab812017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40EQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2EQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULREQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [SUPERVALU INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-186EQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI]6Current NDC, Legacy NDC, 2 package rows20241018_6d34ee3e-3d61-481e-98d6-acfa066e4247.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 9 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d64f5c2-dfa9-e5f5-e063-6294a90a07112025-03-19WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLHarris Teeter, LLC322a71bb-fc68-4a03-8a24-20cbdbe6d91b2025-03-13WarningsExact identifier
application number: M010
REVASOL SLEEP AIDDIPHENHYDRAMINE HCLRnv LLC30131010-be70-c940-e063-6394a90a190a2025-03-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.1a7189ba-2d52-44fc-83a4-b9f6156c62ff2025-03-07WarningsExact identifier
application number: M010
meijer NIGHTTIME Sleep Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bede4cd-bf55-8b84-e063-6394a90aa5c92025-02-19WarningsExact identifier
application number: M010
PHARBEDRYLDIPHENHYDRAMINE HCL 50MGUlai Health LLC135293fb-5674-4638-be55-b968cf51257e2025-01-20WarningsExact identifier
application number: M010
Allergy Relief 25 mgDIPHENHYDRAMINE HCL 25MGUlai Health LLC751f13d4-c4d6-47a5-b40d-1563de08c0482025-01-12WarningsExact identifier
application number: M010
RoboCoughDEXTROMETHORPHAN HBRDXM Pharmacuetical, Inc.32fa7a09-8624-44c1-b9e4-8a8f0594292b2025-01-10WarningsExact identifier
application number: M010
SleepAid (Diphenhydramine HCL)DIPHENHYDRAMINE HCLAPNAR PHARMA LPfaaf5d51-d81d-3acc-e053-6294a90ae08f2025-01-09WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.971515fa-b4d2-1197-e053-2995a90a838d2025-01-03WarningsExact identifier
application number: M010
Nighttime Sleep-Aid SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC8b0fa259-6702-4667-bac6-f7d0b0839ae02025-01-01WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC9f1c078d-e537-4ec0-8ae9-54c98282be292024-12-31WarningsExact identifier
application number: M010
Discount Drugmart Nighttime Sleep-AidDIPHENHYDRAMINE HCLDiscount Drug Mart, Incd6d77c2e-42b3-48f0-a662-3872155ef34d2024-12-18WarningsExact identifier
application number: M010
Kroger Nighttime Sleep-AidDIPHENHYDRAMINE HCLTHE KROGER CO98437a72-1b98-4301-b92f-0c17b305cf592024-12-18WarningsExact identifier
application number: M010
equate nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.6e162152-b414-470c-b146-649d998705772024-12-17WarningsExact identifier
application number: M010
Quality Choice Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association, Inc.e8b2858b-a737-c500-e053-2995a90adba62024-12-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.f99cc210-b946-42a2-9164-8aa5308c54182024-12-11WarningsExact identifier
application number: M010
CalmCo Sleep Aid Gummy BiteDIPHENHYDRAMINE HCLCalmCo LLC0c534cbd-40e6-8af0-e063-6394a90a56052024-12-07WarningsExact identifier
application number: M010
Somnapure Clinical StrengthDIPHENHYDRAMINE HYDROCHLORIDEForce Factor Brands LLC063517c0-bcb1-46dd-85f1-bbb2f24274ef2024-12-06WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.c280cf02-ebb2-4847-a66d-d02aff3ea0c92024-12-02WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN6d34ee3e-3d61-481e-98d6-acfa066e42476
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD6d34ee3e-3d61-481e-98d6-acfa066e42476
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY6d34ee3e-3d61-481e-98d6-acfa066e42476
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY6d34ee3e-3d61-481e-98d6-acfa066e42476

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-186-3041163018630177 mL in 1 BOTTLE (41163-186-30) 177 ml2013-06-280000-00-00NoNoCurrent
41163-186-4041163018640355 mL in 1 BOTTLE (41163-186-40) 355 ml2013-06-280000-00-00NoNoCurrent