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 153 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDENavajo Manufacturing Company Inc.f6068011-ad56-59b4-e053-2995a90ac0162024-10-03WarningsExact identifier
application number: M012
Benadryl UltratabsDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.76433e3c-142c-4704-8b2b-d602f008c3772024-10-02WarningsExact identifier
application number: M012
AfrinOXYMETAZOLINE HYDROCHLORIDENavajo Manufacturing Company Inc.65bf1556-f234-9439-e053-2a91aa0a31942024-10-02WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLProficient Rx LP4eab4344-d95e-4b19-a21e-9c8ad033863a2024-10-01WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLProficient Rx LPa910320b-0585-40bd-928c-0406346281d02024-10-01WarningsExact identifier
application number: M012
CareOne Nasal and Sinus DecongestantPSEUDOEPHEDRINE HCLAmerican Sales Company81b31070-9b03-4ce4-8aac-a334544842ae2024-10-01WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINProficient Rx LP20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d2024-10-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.1bec5167-5fc5-2405-e063-6294a90a53582024-09-30WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutions19b3db33-86d1-48f3-9525-c7c87a4b68992024-09-29WarningsExact identifier
application number: M012
nasal decongestant maximum strength non drowsyPSEUDOEPHEDRINE HCLMeijer Distribution Inc8a68ca99-fd76-409a-9769-88830e8720a82024-09-28WarningsExact identifier
application number: M012
good neighbor pharmacy tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergen58687394-b6d2-4d51-bde0-8f2cfa3fe9092024-09-27WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEAmerisource Bergenfaee3aae-e819-4084-a127-3449be353b132024-09-27WarningsExact identifier
application number: M012
Tesalon ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCLOPMX LLC2309620a-ccbc-41e9-e063-6394a90a95202024-09-26WarningsExact identifier
application number: M012
adult cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.b11c4cee-bbb5-4585-9d38-6787553e13a02024-09-26WarningsExact identifier
application number: M012
COLD AND FLU NIGHTTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9c34e-a0ca-cdf9-e053-2a95a90a93d32024-09-25WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC8f3317f6-4ae8-474b-93c3-25e256519cb82024-09-25WarningsExact identifier
application number: M012
berkley and jensen tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINBJWCb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2024-09-24WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Non DrowsyDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC13eb459c-3075-4038-8062-9ee7175b2ab92024-09-24WarningsExact identifier
application number: M012
equaline nasal decongestant non drowsy maximum strengthPSEUDOEPHEDRINE HCLUnited Natural Foods, Inc. dba UNFI8897580a-709a-4643-8264-ad003d90cbff2024-09-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLDabur India Limited22916978-303d-e62a-e063-6394a90a21002024-09-20WarningsExact 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