FDA.reportPublic FDA data

M-Dryl

Product NDC
58657-528
11-digit product format
586570528
Labeler code
58657
Product ID
58657-528_41b56261-e688-a46d-e063-6394a90a9246
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-01
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
M-Dryl
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
5a60c923-8bb7-427f-9636-08ed5474f71bAvailable 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
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-528-04M-Dryl120 mL in 1 BOTTLELIQUID1206
58657-528-16M-Dryl473 mL in 1 BOTTLELIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-528-04ML - Milliliter58657-528265ac152-5371-4230-857a-ac050c9efddf12019-09-05
58657-528-16ML - Milliliter58657-5287692d868-6561-46ac-8d17-ec2a9710c2c612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-528M-DRYL (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [METHOD PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20241126_5a60c923-8bb7-427f-9636-08ed5474f71b.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 131 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu Nighttime Severe, 24-7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store products, Inc.05d0410f-164e-e7ee-e063-6394a90a2aaa2024-12-16WarningsExact identifier
application number: M012
tussin dm max daytime nighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESINCVS Pharmacy6feaf29e-de06-4c94-912c-a76ea2cbd8c12024-12-16WarningsExact identifier
application number: M012
Leader Childrens Multi Symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER169ff9cf-fcf5-46a6-b460-259421f2ec072024-12-16WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER125eeb3d-0ee2-45bb-81c0-4ca6999798862024-12-16WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mg Liquid GelsDEXTROMETHORPHAN HBRRUGBY LABORATORIEScf3cc387-6642-43fd-999d-688fdaf65d4f2024-12-14WarningsExact identifier
application number: M012
Allergy Relief Dye-Free SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC60b1bb79-3ed1-438b-a27f-f7fbc108d1142024-12-14WarningsExact identifier
application number: M012
Rycontuss Cherry FlavorCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOkendpharma, Inc.c91798fa-48ab-47a0-92da-4d44c2aafde02024-12-13WarningsExact identifier
application number: M012
Mentholatum Lavender Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company6f208c05-617d-492a-a016-e9d6be3c971f2024-12-13WarningsExact identifier
application number: M012
CVS Vapor SteamCAMPHOR (SYNTHETIC)CVS49da2c40-afc5-5770-e054-00144ff88e882024-12-13WarningsExact identifier
application number: M012
Kroger Daytime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Companye428dd83-c538-2a92-e053-2a95a90a0e162024-12-13WarningsExact identifier
application number: M012
Kroger Nighttime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Companye46291c7-6f4d-46a2-e053-2a95a90a80a12024-12-13WarningsExact identifier
application number: M012
Foster and Thrive Childrens Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLC7eaba464-5cdb-4bd4-b272-38fa108658d52024-12-13WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe OriginalOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC1d089074-3969-ce6e-e063-6294a90aa70c2024-12-12WarningsExact identifier
application number: M012
RIGHT REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Incb4fc014c-7c5f-46a4-bf13-57103b6fa0182024-12-11WarningsExact identifier
application number: M012
Diphenhydramine Hydrochloride 25mgDIPHENHYDRAMINE HYDROCHLORIDE 25MGStrive Pharmaceuticals Incb440eb2e-4de9-2b65-e053-2995a90abda82024-12-11WarningsExact identifier
application number: M012
Meijer Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEMeijer Distribution Inc.6933ca9d-a32d-d856-e053-2a91aa0a408e2024-12-10WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEMeijer Distribution Inc.826b5c0d-7a75-bbf0-e053-2a91aa0aebd62024-12-10WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.09141018-37ba-4c93-9051-1ed129c448c12024-12-10WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola USA Inc.6ac9d95b-f6b9-4515-b126-697f8f8396122024-12-10WarningsExact identifier
application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola USA Inc.989d1529-2875-47bf-81df-65494d62be7a2024-12-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNf9a0fb35-46d6-434f-8f9a-425a4bf50e84104
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN9cd10af6-a2fa-44f8-8df3-a6d2a95a5293104
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD9cd10af6-a2fa-44f8-8df3-a6d2a95a5293104
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDf9a0fb35-46d6-434f-8f9a-425a4bf50e84104
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYf9a0fb35-46d6-434f-8f9a-425a4bf50e84104
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY9cd10af6-a2fa-44f8-8df3-a6d2a95a5293104
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYf9a0fb35-46d6-434f-8f9a-425a4bf50e84104
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY9cd10af6-a2fa-44f8-8df3-a6d2a95a5293104
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYf9a0fb35-46d6-434f-8f9a-425a4bf50e84104
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY9cd10af6-a2fa-44f8-8df3-a6d2a95a5293104
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNe1d545dc-9222-4d61-964d-1c781215d7d2102
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDe1d545dc-9222-4d61-964d-1c781215d7d2102
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYe1d545dc-9222-4d61-964d-1c781215d7d2102
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYe1d545dc-9222-4d61-964d-1c781215d7d2102
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYe1d545dc-9222-4d61-964d-1c781215d7d2102
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN5a60c923-8bb7-427f-9636-08ed5474f71b6
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD5a60c923-8bb7-427f-9636-08ed5474f71b6
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY5a60c923-8bb7-427f-9636-08ed5474f71b6
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY5a60c923-8bb7-427f-9636-08ed5474f71b6
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY5a60c923-8bb7-427f-9636-08ed5474f71b6
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN42a0e577-a1b6-2c16-e063-6294a90af8e31
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD42a0e577-a1b6-2c16-e063-6294a90af8e31
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY42a0e577-a1b6-2c16-e063-6294a90af8e31
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY42a0e577-a1b6-2c16-e063-6294a90af8e31
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY42a0e577-a1b6-2c16-e063-6294a90af8e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-528-0458657052804120 mL in 1 BOTTLE (58657-528-04) 120 ml2019-08-010000-00-00NoNoCurrent
58657-528-1658657052816473 mL in 1 BOTTLE (58657-528-16) 473 ml2019-08-010000-00-00NoNoCurrent