FDA.reportPublic FDA data

Allergy Relief

Product NDC
67091-201
11-digit product format
670910201
Labeler code
67091
Product ID
67091-201_fd045871-3a64-468d-93cd-a773a03d4964
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
WinCo Foods, LLC
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
Allergy Relief
Brand name suffix
Complete
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
88e3e51a-c9a5-43f9-b9d7-97509c607df1Available 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
67091-201-24Allergy ReliefComplete12 in 1 BLISTER PACKCAPSULE1215
67091-201-24Allergy ReliefComplete2 in 1 CARTONCAPSULE215

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-201ALLERGY RELIEF COMPLETE (DIPHENHYDRAMINE HCL) CAPSULE [WINCO FOODS, LLC]13Current NDC, Legacy NDC, 2 package rows20240704_88e3e51a-c9a5-43f9-b9d7-97509c607df1.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 42 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCHAIN DRUG MARKETING ASSOCIATION INC7d1b3418-85a8-4ca0-bca7-261b2b58032a2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD, FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Inc.bfc38500-5706-0d03-e053-2995a90a5c722026-03-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP2baa0861-dbef-7910-e063-6394a90a117e2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEFACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17d5ba7-3302-7931-e053-2a95a90a5a6c2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17b8f17-95f6-37e4-e053-2995a90a411a2026-03-26WarningsExact identifier
application number: M012
Ultra concentrated Daytime/ Nighttime Severe SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGELCVS PHARMACY, INC24cedaec-06a6-8fde-e063-6394a90a3d7a2026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEY SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079537-1c06-1373-e063-6394a90a37d22026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2fa8c-071f-50ab-e063-6394a90a4a4a2026-03-26WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3618ccf0-1f30-42e0-bb50-bfa45cf2b5832026-03-26WarningsExact identifier
application number: M012
Vicks childrens Cough Congestion NightPHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company87231460-8b45-b995-e053-2a91aa0a6c432026-03-26WarningsExact identifier
application number: M012
VICKS CHILDRENS COUGH CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyf1d67797-c806-261d-e053-2a95a90a3c152026-03-26WarningsExact identifier
application number: M012
childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inc686f43ea-4296-4eee-b762-9a9e683443402026-03-26WarningsExact identifier
application number: M012
Tussin DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59d3a486-97c2-4e60-90e2-1b5bfa7638c72026-03-26WarningsExact identifier
application number: M012
flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRMeijer Distribution Inc1a853e47-21a2-40e1-9e64-290af4843b132026-03-25WarningsExact identifier
application number: M012
cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Incc4dcc427-aeec-4a26-80f3-02a4b227a5202026-03-25WarningsExact identifier
application number: M012
Walgreens Lavender Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a1a00-852d-2756-e063-6394a90a5e292026-03-25WarningsExact identifier
application number: M012
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company2d56ddcd-3cc8-51eb-e063-6394a90ae7452026-03-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETWIN MED LLC7b000478-649d-4511-b3e0-eea6995b97842026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f32457-23bf-d8a8-e063-6294a90a1e0d2026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEY SUGAR-FREEMedical Group Care LLCf4a9ba87-c2a1-2de0-e053-2a95a90ada4c2026-03-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN88e3e51a-c9a5-43f9-b9d7-97509c607df115
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD88e3e51a-c9a5-43f9-b9d7-97509c607df115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-201-24670910201242 BLISTER PACK in 1 CARTON (67091-201-24) / 12 CAPSULE in 1 BLISTER PACK2 blister pack1990-03-150000-00-00NoNoCurrent