FDA.reportPublic FDA data

Dimetane

Product NDC
57237-367
Requested package NDC
57237-367-99
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 111 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentrexcilina Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e5c17-28f2-7186-e053-2995a90a51f62025-07-17WarningsExact identifier
application number: M012
Viro Flu PM ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe1553da8-3a89-e258-e053-2a95a90a47252025-07-17WarningsExact identifier
application number: M012
ACTICON PEDIATRICDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC3052cc67-e6c0-4d3f-9ec9-ffe58d9fae232025-07-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDemoulas Super Markets, Inc397f5acd-31c0-683e-e063-6394a90a7e542025-07-16WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC19ad2cca-c1cb-019c-e063-6294a90a56442025-07-16WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp Inc8ea03891-2fbc-4413-8e6d-de903d426f8d2025-07-16WarningsExact identifier
application number: M012
up and up nighttime flu and severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationdf488727-b913-440b-9a0b-cce3ae143bf22025-07-15WarningsExact identifier
application number: M012
Topcare DayTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCbb9663e3-fd11-4e72-bf85-fee4841b795f2025-07-15WarningsExact identifier
application number: M012
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Inc320e4f32-66aa-48be-9afd-fa2b2c217dc12025-07-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.f29da4ca-443d-7035-e053-2a95a90acab82025-07-14WarningsExact identifier
application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS PHARMACYcdc9af7c-3766-4573-9d95-bf217907b9322025-07-11WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILInternational Wholesale Inc398fee3d-7d93-9dbc-e063-6294a90abdcc2025-07-10WarningsExact identifier
application number: M012
HEADACHE RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINEKroger Companybbed29a1-3c52-3531-e053-2995a90a686c2025-07-10WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCb765c82e-5021-4772-8647-c5ebc596bc0a2025-07-10WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyc378acaf-389a-4afb-a4f0-e367a907a4682025-07-10WarningsExact identifier
application number: M012
Nasal Decongestant Non-DrowsyPSEUDOEPHEDRINE HCLCVS Pharmacy3330b077-dab7-45c6-acbb-0f91f22712322025-07-09WarningsExact identifier
application number: M012
ACTIDOGESIC DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEACTIPHARMA, LLCff8e2565-bce3-4c06-a416-6e8f369f057f2025-07-09WarningsExact identifier
application number: M012
ACTINELDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLCdb0cb6ae-0a4d-4232-805a-f3f3a058261f2025-07-08WarningsExact identifier
application number: M012
HALLS Extra StrongMENTHOLMondelez Global LLC396f93a9-8d2c-2f27-e063-6294a90ab3442025-07-08WarningsExact identifier
application number: M012
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLCaea0335d-75e6-4a90-86a5-f197cf024a112025-07-08WarningsExact 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
57237-367-99572370367991000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-99) 2026-01-27NoNoCurrent