FDA.reportPublic FDA data

Allergy Relief

Product NDC
49035-901
11-digit product format
490350901
Labeler code
49035
Product ID
49035-901_a627efa4-b920-4b38-9b2d-e08fc3ec0087
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Wal-Mart Stores 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
Allergy Relief
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
c88e93d4-66b6-4327-b9e5-0e0a95a18d66Available 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
49035-901-08Allergy Relief2 in 1 CARTONCAPSULE218
49035-901-08Allergy Relief12 in 1 BLISTER PACKCAPSULE1218
49035-901-12Allergy Relief100 in 1 BOTTLE, PLASTICCAPSULE10018
49035-901-12Allergy Relief1 in 1 CARTONCAPSULE118
49035-901-42Allergy Relief12 in 1 BLISTER PACKCAPSULE1218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-901-12EA - Each49035-901a478687b-ed82-4502-bff1-1547021160c012017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
GELATININACTIVE INGREDIENT2G86QN327LALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALLERGY (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-901ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [WAL-MART STORES INC]16Current NDC, Legacy NDC, 5 package rows20240623_c88e93d4-66b6-4327-b9e5-0e0a95a18d66.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 2 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
application number: M012
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
application number: M012
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
application number: M012
tabcin Extra StrengthDEXTROMETHORPHAN HBR, GUAIFENESINOPMX LLC23223821-4fa0-5d99-e063-6394a90af0e52026-09-07WarningsExact identifier
application number: M012
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
application number: M012
NostrillaOXYMETAZOLINE HYDROCHLORIDEInsight Pharmaceuticals LLC86217847-8e2b-48cc-b289-4987fd3aa7c32026-09-04WarningsExact identifier
application number: M012
tussin cough chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation86fc3723-5fc5-4de5-bd04-7774c2abe5392026-09-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
application number: M012
tussin nighttime coughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation80d51af8-3a7b-4d22-8d4f-df5f919130472026-09-04WarningsExact identifier
application number: M012
NO MORE NOSEBLEEDOXYMETAZOLINE HYDROCHLORIDEDR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.69d3f1fe-b476-4f84-8c5e-94957b74b46c2026-09-04WarningsExact identifier
application number: M012
Ultra Fine Mist Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEDOLGENCORP, INC.5f134840-2465-4585-a85d-08d746f76f7a2026-09-03WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATEFamily Dollar (FAMILY WELLNESS)22918db6-9096-4eb8-a742-aaa2dd5c31da2026-09-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNc88e93d4-66b6-4327-b9e5-0e0a95a18d6618
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDc88e93d4-66b6-4327-b9e5-0e0a95a18d6618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-901-08490350901082 BLISTER PACK in 1 CARTON (49035-901-08) / 12 CAPSULE in 1 BLISTER PACK2 blister pack1990-03-150000-00-00NoNoCurrent
49035-901-12490350901121 BOTTLE, PLASTIC in 1 CARTON (49035-901-12) / 100 CAPSULE in 1 BOTTLE, PLASTIC1990-03-150000-00-00NoNoCurrent
49035-901-424903509014212 CAPSULE in 1 BLISTER PACK (49035-901-42) 12 capsule1990-03-150000-00-00NoNoCurrent