FDA.reportPublic FDA data

Diphenhist

Product NDC
0536-0770
11-digit product format
005360770
Labeler code
0536
Product ID
0536-0770_93647dad-3daf-f7c5-e053-2995a90a2974
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Rugby Laboratories Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-09-26
Marketing end
2020-09-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-0770DDiscontinued by firm2026-10-05
excluded packagepackage0536-07700536-0770-85DDiscontinued by firm2026-10-05
excluded packagepackage0536-07700536-0770-97DDiscontinued by firm2026-10-05

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-0770-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-0770-97d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-0770-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-0770-97f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-0770-852ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-0770-972ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-0770-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-0770-97a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-0770-85cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-0770-97cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-0770-85cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-0770-97cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-0770-85302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-0770-97302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-0770-85ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-0770-97ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-0770-850efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-0770-970efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-0770-85ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-0770-97ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-0770-85367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-0770-97367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-0770-85557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-0770-97557ba5c1ecfa…9c80585c8c6e…

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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-0770-85ML - Milliliter0536-0770e03b2736-9fbd-43c6-85fe-8cddbf0fd7b612012-07-24
0536-0770-97ML - Milliliter0536-0770c24b0599-4120-463b-bed7-43ba725e87cc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
DiphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
DiphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RDIPHENHIST (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092456Diphenhist 12.5 MG in 5 mL Oral SolutionPSNeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91
1092456diphenhydramine hydrochloride 2.5 MG/ML Oral Solution [Diphenhist]SBDeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91
1092456Diphenhist 12.5 MG per 5 ML ElixirSYeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91
1092456Diphenhist 2.5 MG/ML Oral SolutionSYeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYeefc47ff-ed87-4f98-9fa2-9cb1a0793ba91