FDA.reportPublic FDA data

Dimetane

Product NDC
57237-367
11-digit product format
572370367
Labeler code
57237
Product ID
57237-367_958e9dae-4d1c-40fc-b84d-20f2ed6996c0
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-27
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
2027-12-31
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
Dimetane
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
8GTS82S83MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020477Internal RxNorm lookup
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
484d6a37-b84e-4ead-bb89-9c3d8c3bcd2fAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-367-01Dimetane100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
57237-367-99Dimetane1000 in 1 BOTTLECAPSULE, LIQUID FILLED10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-367-01EA - Each57237-367e5cbb116-bb64-4ac1-b056-693aaf67837712026-02-05
57237-367-99EA - Each57237-36752918ffe-99b2-4ea2-b110-01ee01c5a25c12026-02-05

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 81 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Basic Care Honey Lemon Cough DropsMENTHOLAmazon.comc0937b13-f679-a764-e053-2a95a90abf892025-12-05WarningsExact identifier
application number: M012
Basic Care SF Menthol Cough DropsMENTHOLAmazon.comc0946295-7cf0-1bd8-e053-2a95a90af5af2025-12-05WarningsExact identifier
application number: M012
Basic Care SF Honey Lemon Cough DropsMENTHOLAmazon.comcf82fb0b-1b4d-def1-e053-2995a90a6fd92025-12-05WarningsExact identifier
application number: M012
G-DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis7a4e1d64-2510-405f-a1dc-e02a803b6fbd2025-12-05WarningsExact identifier
application number: M012
Quality Choice Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEChain Drug Manufacturing Assnce658dd5-b683-436e-b16b-0c06f6f87fd92025-12-04WarningsExact identifier
application number: M012
Quality Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa87ba15f-b5a9-4983-a721-ca7f705aea862025-12-04WarningsExact identifier
application number: M012
Quality ChoicePHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa12e2e66-d2f3-47a6-a915-a309ae828d272025-12-04WarningsExact identifier
application number: M012
Childrens Mucus Relief Chest CongestionGUAIFENESINChain Drug Manufacturing Assn034d39c0-9aad-4dff-a158-a041b9f0504f2025-12-04WarningsExact identifier
application number: M012
Quality ChoiceOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd01b8fb6-1ddf-4901-bda6-ae608e94a6a42025-12-04WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEChain Drug Manufacturing Assn06822a28-3f82-471d-8db5-c5981b263a032025-12-04WarningsExact identifier
application number: M012
QUALITY CHOICEPHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION14596551-dd82-46b3-8eb8-e69efaea105b2025-12-04WarningsExact identifier
application number: M012
Daytime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Incfd5c20ed-5520-4db0-bfd4-995f043af2a42025-12-04WarningsExact identifier
application number: M012
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.89c165ba-3ad5-49b5-a5bb-423dc8e15bad2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Powerfast Fizz NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a2b30c27-b836-f09f-e053-2995a90ac3832025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast FizzASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.a37c9d9d-52db-23ff-e053-2995a90a8f762025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Cough PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a68df74d-dd26-3ae9-e053-2995a90a08d62025-12-04WarningsExact identifier
application number: M012
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.55662ada-677e-4048-9529-5bca440763162025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.b13d5132-cb91-3cf6-e053-2a95a90aa47c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast FizzCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.bd97e91f-1ae1-379c-e053-2995a90acfdd2025-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f1
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f1
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f1
1020477diphenhydramine HCl 50 MG Oral CapsuleSY484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
57237-367-0157237036701100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-01) 2026-01-27NoNoCurrent
57237-367-99572370367991000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-99) 2026-01-27NoNoCurrent