FDA.reportPublic FDA data

Pharbedryl

Product NDC
16103-348
11-digit product format
161030348
Labeler code
16103
Product ID
16103-348_1c298805-036e-4cd1-87cc-1d2e413043b8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-348-03IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-348-08IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-348-11IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-348-03IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-348-08IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-348-11IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16103-348-11EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16103-348-08EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16103-348-03EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Pharbedryl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
070e556b-e083-452f-8a7c-aca92470dd61Available 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, Related label table
NDCEffectiveRelated label
16103-348-032023-06-13Drug Facts
16103-348-082023-06-13Drug Facts
16103-348-112023-06-13Drug Facts
16103-348-032023-01-30Drug Facts
16103-348-082023-01-30Drug Facts
16103-348-112023-01-30Drug Facts
16103-348-032021-03-30Drug Facts
16103-348-082021-03-30Drug Facts
16103-348-112021-03-30Drug Facts
16103-348-032020-01-31Drug Facts
16103-348-082020-01-31Drug Facts
16103-348-112020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-348-08Pharbedryl100 in 1 BOTTLE, PLASTICCAPSULE1005
16103-348-08Pharbedryl1 in 1 CARTONCAPSULE15
16103-348-11Pharbedryl1000 in 1 BOTTLE, PLASTICCAPSULE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-348-03EA - Each16103-3485de1d9de-7e1e-4271-80c4-090cadb9fcd812012-07-24
16103-348-08EA - Each16103-34890cd3e96-3e7f-40bb-a237-08d4664982ea12014-12-01
16103-348-11EA - Each16103-3483310a6e3-4317-40ac-a106-9f7606a265f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-348PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20250101_070e556b-e083-452f-8a7c-aca92470dd61.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 3 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCLRite Aid Corporationfbedb50d-b96f-4ce4-a1dc-d2b357cf6de12026-05-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLFamily Dollar Services Inc8ebd9949-ef53-4d66-a20c-3e0047b3e1ef2026-05-13WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS Pharmacy0be4ef9a-2484-41dd-8bb8-e92d411f13842026-05-11WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLAMERISOURCE BERGENca052b38-de38-7bf0-e053-2995a90a4e852026-05-11WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCe68d96c8-21c5-406c-b22c-3e384027c79f2026-05-07WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLKroger Companyb71bb567-5605-430b-b3fa-048fe9bbe8ff2026-05-04WarningsExact identifier
application number: M010
Sleep II Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreen Companyed864c84-a430-4ca8-87e8-04f1c1df538b2026-05-04WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreen Companyf8f17615-e4ec-49d4-9c0d-581d0fd6feb72026-04-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLL.N.K. International, Inc.888dc258-d5a3-4b62-aea1-c81ea29ff6f52026-04-28WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen8f1cb631-4633-4ef5-868e-48a46ab311a42026-04-27WarningsExact identifier
application number: M010
Nightime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBETTER LIVING BRANDS LLC.202bb1ff-3273-4872-e063-6294a90abebb2026-04-11WarningsExact identifier
application number: M010
Vicks ZzzQuil Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company1be2f00b-5bdd-82e7-e063-6394a90ab9a52026-04-06WarningsExact identifier
application number: M010
Night Time Sleep AidDIPHENHYDRAMINE HCLHyVee Inccf94fa56-01a5-4d6c-ad08-38b0ea3633992026-04-03WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICE84ec323d-0523-41e8-856c-e02d6afdc9ec2026-04-02WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI6c9b7576-428a-4884-8331-bb312c9046bd2026-04-01WarningsExact identifier
application number: M010
Calmco Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC471d4c70-813a-19de-e063-6394a90aeb252026-03-31WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLThe Kroger Co.0db543bb-c6c3-4370-a70c-e1652781fd7d2026-03-25WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 50MGGrocery Outlet57a751e9-d8b6-4527-8537-bc4be718f5ec2026-03-17WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLWalgreen Companydf7a43d1-83a7-4e86-baef-4b9d1ebf0dbb2026-03-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.4454df6a-931f-3f03-e063-6294a90afe732026-03-14WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1ee41c86-6767-43ca-a5bb-fc685fa662cd13
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1ee41c86-6767-43ca-a5bb-fc685fa662cd13
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN070e556b-e083-452f-8a7c-aca92470dd615
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD070e556b-e083-452f-8a7c-aca92470dd615
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3ef18965-bafb-cc19-e063-6394a90af17d2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3ef18965-bafb-cc19-e063-6394a90af17d2
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN58ec2d97-168b-505a-e053-2991aa0a39781
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD58ec2d97-168b-505a-e053-2991aa0a39781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16103-348-03161030348031 BOTTLE, PLASTIC in 1 CARTON (16103-348-03) > 24 CAPSULE in 1 BOTTLE, PLASTIC2016-02-010000-00-00NoNoCurrent
16103-348-08161030348081 BOTTLE, PLASTIC in 1 CARTON (16103-348-08) / 100 CAPSULE in 1 BOTTLE, PLASTIC2016-02-010000-00-00NoNoCurrent
16103-348-11161030348111000 CAPSULE in 1 BOTTLE, PLASTIC (16103-348-11) 1000 capsule2016-02-010000-00-00NoNoCurrent