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
8GTS82S83MInternal UNII lookup
TC2D6JAD40Internal 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 176 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER PLUS Cold Day and Night EffervescentASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATESincronia Logistica, S.A. de C.V.c478df69-823a-4112-8f44-323249a9f38f2023-10-23WarningsExact identifier
application number: M012
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC169006cb-7dc2-4113-a289-0b1f14e784b72023-10-23WarningsExact identifier
application number: M012
Night-Time Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealthLife of USA2ffd62a6-703f-4cb0-bb13-49719c004d002023-10-21WarningsExact identifier
application number: M012
Day-Time Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHANHealthLife of USAc5f6cf22-2aaa-40e1-b7b3-448e55898d622023-10-21WarningsExact identifier
application number: M012
PENTREXCILINAACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEHealthlife of USAae9ada14-0ec8-4c01-a874-237f2108936a2023-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINAPNAR PHARMA LPe5004c10-3877-c199-e053-2a95a90aa8ac2023-10-21Boxed warning, WarningsExact identifier
application number: M012
Day and Night Multi Symptom Cold and Flu ReliefDAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEFIntrivo Diagnostics Inc.a311bf39-de6c-4ed5-949e-718ad8be1e492023-10-13WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0d65c4a9-938c-4a89-b1f1-d9ada8a8c5872023-10-10WarningsExact identifier
application number: M012
Triacting Daytime Cold Cough ChildrensDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8656aa2e-9546-4de4-9ecc-ce99bf9033332023-10-10WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreensa33ae35b-1cde-4a3d-a836-3b169e4f1bb92023-10-10WarningsExact identifier
application number: M012
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)553d01a9-e8ad-4797-b55b-32f134f08af92023-10-10WarningsExact identifier
application number: M012
Mucus Relief Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens8781e2c5-ad46-4615-a0d9-879590e86f952023-10-10WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens419df833-1f33-45cf-bab3-730c928d58872023-10-10WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)93a5cb36-3262-4224-a5be-5ea1619a67bd2023-10-10WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINCVS Pharmacy782fb103-cd9f-4e8c-8f3a-1fb131b9eda62023-10-09WarningsExact identifier
application number: M012
Cold and Congestion Childrens NighttimeDIPHENHYDRAMINE HCI, PHENYLEPHRINE HCLWalgreensa7847413-e556-4f88-8a7f-a8528afbe9272023-10-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLC06d2c6cf-0adb-91b9-e063-6294a90aff522023-10-03WarningsExact identifier
application number: M012
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIXACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b2023-10-02WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.ac8c0c15-b305-47f2-8712-e4b53636f7fa2023-10-02WarningsExact identifier
application number: M012
Maximum strength Day cold and flu and Night severe cold and fluACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETSTIME CAP LABORATORIES,INCfff69901-965c-5372-e053-6394a90a29c22023-09-18WarningsExact 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