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 172 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDeMoulas Market Baskete92d2f64-9690-42d3-b787-cafade3a89992023-12-29WarningsExact identifier
application number: M012
Cold and Sinus Maxium StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basket6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2023-12-29WarningsExact identifier
application number: M012
Cold, Flu and Sore Throat Maxium StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketd98029c0-ccd9-47e1-996f-c7786cd4ecca2023-12-29WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC0f2be061-bd0a-4e62-b994-6d0768ea647a2023-12-29WarningsExact identifier
application number: M012
Tussin CF Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketc19b9997-4037-48f3-b905-86da421a292d2023-12-29WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.0239ada0-644d-4ef4-a3b8-df70246a3bc22023-12-21WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.a698502d-c1c5-41ca-8142-74338b834c8b2023-12-21WarningsExact identifier
application number: M012
Father Johns Cough Medicine PlusNASAL DECONGESTANTOakhurst Company8b8aab0f-251b-6bd8-e053-2995a90ad7482023-12-18WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBROakhurst Company8b8a249d-55af-cc98-e053-2995a90a431d2023-12-18WarningsExact identifier
application number: M012
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79d92d2-d73c-d44f-e053-2995a90a03d92023-12-15WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCL TABLETLil' Drug Store Products, Inc.e5339c39-1d66-b283-e053-2995a90a43172023-12-15WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBRHumco Holding Group, Inca7b0669f-8da1-5a44-e053-2995a90a84d92023-12-15WarningsExact identifier
application number: M012
Ephedrine HydrochlorideEPHEDRINE HYDROCHLORIDEWalgreen Companybcb81dc1-d854-30c0-e053-2a95a90a9fc72023-12-14WarningsExact identifier
application number: M012
Allergy, Circle KDIPHENHYDRAMINE HCL 25MG TABLETLil' Drug Store Products, Inc.d1f370ac-e7f4-baf7-e053-2995a90a1e502023-12-14WarningsExact identifier
application number: M012
Circle K Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.a6a1e3d9-575c-4adf-beb6-c9719de55c672023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Sinus Severe, Circle KACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store products, Inc.e78c456f-f62e-596d-e053-2995a90a23972023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Max ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79f1a92-d8ea-e3f9-e053-2a95a90a2d372023-12-14WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsbcc1a001-4176-485d-aaf0-2037ca65c6b82023-12-14WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsedb49b17-06a7-4c25-bc7c-d62c1deac7f12023-12-13WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline No DripOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)0c006b1c-8ab2-4b9c-8738-e7001c1bb47d2023-12-11WarningsExact 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