NIGHTTIME SLEEP AID Maximum Strength

Product NDC
49035-237
Requested package NDC
49035-237-16
11-digit product format
490350237
Labeler code
49035
Product ID
49035-237_b65203a1-0b17-493b-a0f3-b8315d739bf7
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
EQUATE (Walmart Stores, Inc.)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-31
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage49035-23749035-237-16IInactivated by FDA2026-10-16

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-237-162025-01-30C16284748780-12cef2736-b114-d83d-e063-dadaa90ab31fNighttime Sleep-Aid
49035-237-962025-01-30C16284748780-12cef2736-b114-d83d-e063-dadaa90ab31fNighttime Sleep-Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-237-16NIGHTTIME SLEEP AID Maximum Strength32 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED323
49035-237-16NIGHTTIME SLEEP AID Maximum Strength1 in 1 CARTONCAPSULE, LIQUID FILLED13
49035-237-96NIGHTTIME SLEEP AID Maximum Strength96 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED963

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-237NIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE 50 MG) CAPSULE, LIQUID FILLED [EQUATE (WALMART STORES, INC.)]3Legacy NDC, 3 package rows20191122_2b1af499-623e-4f6a-949b-21abf276b65d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN2b1af499-623e-4f6a-949b-21abf276b65d3
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD2b1af499-623e-4f6a-949b-21abf276b65d3
1020477diphenhydramine HCl 50 MG Oral CapsuleSY2b1af499-623e-4f6a-949b-21abf276b65d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-237-16490350237161 BOTTLE, PLASTIC in 1 CARTON (49035-237-16) > 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2013-10-310000-00-00NoNoCurrent