FDA.reportPublic FDA data

equate allergy relief

Product NDC
49035-379
11-digit product format
490350379
Labeler code
49035
Product ID
49035-379_554e8fbd-4161-49e3-a902-fee759a055b8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-08-15
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-37949035-379-34DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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
equate allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

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
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b05acd16-21cb-4ee0-afa0-8f7d59166435Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-379-262024-01-30C16284748780-11030e365-15da-111a-e063-dadaa90a10e2Wal-Mart Children’s Allergy Relief Drug Facts
49035-379-342024-01-30C16284748780-11030e365-15da-111a-e063-dadaa90a10e2Wal-Mart Children’s Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-379-26equate allergy relief118 mL in 1 BOTTLESOLUTION1186
49035-379-26equate allergy relief1 in 1 CARTONSOLUTION16
49035-379-34equate allergy relief237 mL in 1 BOTTLESOLUTION2376
49035-379-34equate allergy relief1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-379-26ML - Milliliter49035-3791d145837-5960-4e41-b163-a02054cd021b12012-07-24
49035-379-34ML - Milliliter49035-379663db70b-bf51-4062-b078-75e4c14610f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40EQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2EQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULREQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3
WATERINACTIVE INGREDIENT059QF0KO0REQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-379EQUATE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES INC]6Current NDC, Legacy NDC, 4 package rows20240725_b05acd16-21cb-4ee0-afa0-8f7d59166435.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 103 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.3862aaa5-2281-e8f9-e063-6294a90a0f7e2025-09-09WarningsExact identifier
application number: M012
McKesson Sugar Free Cough Suppressant Oral AnestheticMENTHOL LOZENGEMcKesson Medical-Surgicale0dfa6ca-b311-25cb-e053-2a95a90a12cc2025-09-09WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione648f017-9e30-df6c-e053-2995a90adcd02025-09-09WarningsExact identifier
application number: M012
Medi-First Honey Lemon Cough DropsMENTHOL 8.6 MGUnifirst First Aid Corporation826e1b87-e5a9-8637-e053-2991aa0aded12025-09-09WarningsExact identifier
application number: M012
Unishield Cherry CoughMENTHOLUnishieldb8297bc1-44b2-3de0-e053-2995a90ad01b2025-09-09WarningsExact identifier
application number: M012
McKesson Cough SupressantMENTHOLMcKesson Medical-Surgicaldb5e0490-2ed8-2d53-e053-2a95a90a98f52025-09-09WarningsExact identifier
application number: M012
Duratuss ACCODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.3e5ed178-d5d9-b8d4-e063-6394a90a91db2025-09-09WarningsExact identifier
application number: M012
Rompe Pecho CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLEfficient Laboratories Inc96c4dee1-6e66-4442-a7e3-56e874414c172025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc57c458ed-7987-453b-ab24-bbfa6580f9202025-09-09WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.38637189-d1ee-9405-e063-6394a90ae8b82025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreensfd52d8d8-7cd1-4e92-86da-354a1d5213c22025-09-08WarningsExact identifier
application number: M012
Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione8e5fb21-a7fd-44d1-b9c4-83e949699ca62025-09-08WarningsExact identifier
application number: M012
Medi-First Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation9654f5cd-74d7-44a2-9674-666d1e94ffa72025-09-08WarningsExact identifier
application number: M012
Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationf196f2c5-a100-42b1-bd01-0327b223838e2025-09-08WarningsExact identifier
application number: M012
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsExact identifier
application number: M012
Green Guard Allergy 2 ReliefPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation16fddca9-a66b-41e6-9423-eaf091d3971e2025-09-08WarningsExact identifier
application number: M012
Medique Medi-PhenylPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationd7d62ac1-1333-4366-884b-26537766ce382025-09-08WarningsExact identifier
application number: M012
Unishield Sinus DecongestantPHENYLEPHRINE HCLUnishieldb8f68d9d-2d38-414a-e053-2a95a90a15ec2025-09-08WarningsExact identifier
application number: M012
McKesson Sinus Pain and Pressure ReliefACETAMINOPHEN, PHENYLEPHRINE HCLMcKesson Medical-Surgicale0cbb213-4f4f-4045-e053-2a95a90a2a182025-09-08WarningsExact identifier
application number: M012
Medique Medicidin DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation1f172d58-4050-424b-9743-130d8e618fe82025-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNb05acd16-21cb-4ee0-afa0-8f7d591664356
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDb05acd16-21cb-4ee0-afa0-8f7d591664356
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYb05acd16-21cb-4ee0-afa0-8f7d591664356
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYb05acd16-21cb-4ee0-afa0-8f7d591664356
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYb05acd16-21cb-4ee0-afa0-8f7d591664356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-379-26490350379261 BOTTLE in 1 CARTON (49035-379-26) / 118 mL in 1 BOTTLE1 bottle1990-08-150000-00-00NoNoCurrent
49035-379-34490350379341 BOTTLE in 1 CARTON (49035-379-34) > 237 mL in 1 BOTTLE1 bottle1999-02-170000-00-00NoNoCurrent