FDA.reportPublic FDA data

Complete Allergy Medicine

Product NDC
57243-190
11-digit product format
572430190
Labeler code
57243
Product ID
57243-190_45283399-3bf4-4563-9b83-ae4b600b0f1a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Salado Sales, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-15
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
Complete Allergy Medicine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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
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
c0f5c8ca-b187-40bf-9245-6a29f1c32c97Available 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
57243-190-08Complete Allergy Medicine2 in 1 CARTONCAPSULE218
57243-190-08Complete Allergy Medicine12 in 1 BLISTER PACKCAPSULE1218

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40COMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCOMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8COMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCOMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCOMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCOMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-190COMPLETE ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) CAPSULE [SALADO SALES, INC.]17Current NDC, Legacy NDC, 2 package rows20250125_c0f5c8ca-b187-40bf-9245-6a29f1c32c97.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 173 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AkinGUAIFENESINSouthern Sales & Service, Inc.bb2c9f21-6765-4286-bd71-de01cdf4c4e92023-11-29WarningsExact identifier
application number: M012
Akin Cough Formula DMDEXTROMETHORPHAN, GUAIFENESINSouthern Sales & Service, Inc.1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a2023-11-29WarningsExact identifier
application number: M012
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESimpex Pharma Pvt. Ltd82771f6a-8b3d-4ffa-8b35-09c2faf3582c2023-11-29WarningsExact identifier
application number: M012
SIMPEX GuaifenesinGUAIFENESINSimpex Pharma Pvt. Ltd1594f9d6-0c48-42bf-b76b-d621f215179a2023-11-29WarningsExact identifier
application number: M012
StonaACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.8b89f50d-88f8-4773-92ea-5ada617660562023-11-28WarningsExact identifier
application number: M012
StonaDEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.1ccc9e56-32a4-450f-8412-5814b6aef2852023-11-28WarningsExact identifier
application number: M012
Neo-Synephrine MaximumPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab8682a4-1f66-6709-e053-2995a90a8b4a2023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab860c10-b8cf-3f92-e053-2a95a90a73172023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC9b8e9162-e4da-14d9-e053-2995a90a22692023-11-16WarningsExact identifier
application number: M012
Universal Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUSUniversal Distribution Center LLCb1d25572-da21-408d-aab3-3a0741dfff122023-11-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Severe, Caseys 4googACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATEDLil' Drug Store Products, Inc.0334259d-587e-b2d5-e063-6394a90a3e562023-11-14WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSato Pharmaceutical Co., Ltd.0b638db4-5ed3-4665-abcd-f95e677adbd82023-11-12WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc6c90b415-4c5f-49e5-beb6-4cf225797b212023-11-06WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc8b8582c0-8aef-482f-9738-2f1d4e325d642023-11-06WarningsExact identifier
application number: M012
Cold and Flu Severe Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC27ade5f8-2003-4dc6-9244-42676791e1f82023-11-06WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Incec2070df-8a8a-4cd1-8830-62655433fb3b2023-11-05WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION093eed84-79b1-7914-e063-6394a90a37af2023-11-03WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff68377-2273-6c6c-e053-2995a90a36b22023-11-03WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLC096bbcaa-fce1-0fc2-e063-6294a90ad5972023-11-03WarningsExact identifier
application number: M012
TopCare Nite Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCadc8edf5-ebbe-4d94-9018-aa0dbe1181122023-11-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNc0f5c8ca-b187-40bf-9245-6a29f1c32c9718
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDc0f5c8ca-b187-40bf-9245-6a29f1c32c9718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57243-190-08572430190082 BLISTER PACK in 1 CARTON (57243-190-08) / 12 CAPSULE in 1 BLISTER PACK2 blister pack1990-03-150000-00-00NoNoCurrent