FDA.reportPublic FDA data

Diphenhydramine HCL

Product NDC
84447-103
11-digit product format
844470103
Labeler code
84447
Product ID
84447-103_3765beab-e853-b34f-e063-6394a90ac9d5
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
SOLUTION
Route
ORAL
Labeler
Belleview Biosciences
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-20
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

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
Diphenhydramine HCL
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
1db57d86-39f0-f8ca-e063-6394a90a6397Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84447-103-01Diphenhydramine HCL200000 mL in 1 DRUMSOLUTION2000002
84447-103-04Diphenhydramine HCL118 mL in 1 BOTTLE, PLASTICSOLUTION1182
84447-103-16Diphenhydramine HCL473 mL in 1 BOTTLE, PLASTICSOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84447-103-16ML - Milliliter84447-1033fbeb6a1-3362-4f18-b499-87b41d9d205c12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84447-103DIPHENHYDRAMINE HCL SOLUTION [BELLEVIEW BIOSCIENCES]1Current NDC, 3 package rows20241109_1db57d86-39f0-f8ca-e063-6394a90a6397.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 125 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.2ee2b332-9b85-45a6-b242-3f0ebfbd08a62024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCaebc7cf8-aaf7-4746-89f5-a64d0be1641e2024-12-26WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa1661a66-5e8c-4144-9c82-cbbcc75fb2222024-12-23WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLGERI-CARE PHARMACEUTICALS, CORP34d36146-6827-4800-8483-c0edb8f4cc282024-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp6299e352-116e-43f2-b40f-c704a7bd5d612024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion ReliefGUAIFENESINUnited Natural Foods, Inc. dba UNFIad9fde8b-10cd-4778-917d-1ed6b67e5ab12024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINUnited Natural Foods, Inc. dba UNFIa40f5893-eb96-4e0e-b965-d78293c48dc92024-12-23WarningsExact identifier
application number: M012
Tukol X-Pecto Miel Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.b9d32964-5bd7-44b0-be98-827d5310ed4f2024-12-20WarningsExact identifier
application number: M012
Halls Honey VanillaMENTHOLMondelez Global LLC8e94a1b8-8915-4595-b097-8a0a319d54aa2024-12-20WarningsExact identifier
application number: M012
Halls Sugar Free Mentho-LyptusMENTHOLMondelez Global LLC96046858-c57b-426e-8279-91b35e05bcdb2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best ChoiceLEVMETAMFETAMINEValu Merchandisers Company3f1c086c-bc22-4abb-9921-565a13f30c202024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTWalgreens77924474-ccc7-497b-9168-91490bcfadfc2024-12-20WarningsExact identifier
application number: M012
LevmetamfetamineLEVMETAMFETAMINEMeijer, Inc.d11e916f-90a6-4099-bf83-75f2dfbd62662024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG healthLEVMETAMFETAMINEDolgencorp Inc.5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd32024-12-20WarningsExact identifier
application number: M012
Tukol Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.aef2ad43-145d-4abc-bccc-2c5fdd6882f92024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare healthLEVMETAMFETAMINETopco Associates LLC8f995561-759a-4837-a82a-640417a6f8892024-12-20WarningsExact identifier
application number: M012
Childrens CoughDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores, Inc.50a0eaa5-fa73-4d84-86fc-3546c85cf3532024-12-20WarningsExact identifier
application number: M012
Equate Childrens Multi symptom Cold NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee2024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTC.D.M.A., Inc.904b7e21-cce5-4b96-afc1-b36f532f98ac2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, EqualineLEVMETAMFETAMINESupervalu Inc.44f72f34-d0b8-421f-b240-86286de874cf2024-12-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1db57d86-39f0-f8ca-e063-6394a90a63972
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1db57d86-39f0-f8ca-e063-6394a90a63972
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1db57d86-39f0-f8ca-e063-6394a90a63972
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1db57d86-39f0-f8ca-e063-6394a90a63972
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1db57d86-39f0-f8ca-e063-6394a90a63972
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2f871005-de4d-8b2a-e063-6394a90aa43a1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2f871005-de4d-8b2a-e063-6394a90aa43a1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2f871005-de4d-8b2a-e063-6394a90aa43a1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2f871005-de4d-8b2a-e063-6394a90aa43a1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2f871005-de4d-8b2a-e063-6394a90aa43a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84447-103-0184447010301200000 mL in 1 DRUM (84447-103-01) 200000 ml2024-07-20NoNoCurrent
84447-103-0484447010304118 mL in 1 BOTTLE, PLASTIC (84447-103-04) 118 ml2024-07-20NoNoCurrent
84447-103-1684447010316473 mL in 1 BOTTLE, PLASTIC (84447-103-16) 473 ml2024-07-20NoNoCurrent