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 89 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G-Supress DXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5dd44337-f3aa-4e73-a206-4a29850a2f7c2025-11-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC15b3de6c-7ccc-408b-8789-d0e2f21a88352025-11-12WarningsExact identifier
application number: M012
PRESGEN PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVIS12fb91e5-6059-4b3a-a2de-762aa51a25b72025-11-12WarningsExact identifier
application number: M012
SorbugenDEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATEKramer Novisa8f2a2d7-0360-45a8-9635-c852f4a7d7ba2025-11-12WarningsExact identifier
application number: M012
DESGEN DMDEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCLKramer Novis6ab47174-e1fd-47ce-8788-06b7cdad52182025-11-12WarningsExact identifier
application number: M012
PresgenGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novisedad7a86-0d27-4a98-85b2-4b6725904f282025-11-12WarningsExact identifier
application number: M012
TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novise966b75c-4bb4-4216-8247-baada8f5d7592025-11-12WarningsExact identifier
application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)52327ed0-ea49-4d1c-b928-20ab381be9f22025-11-11WarningsExact identifier
application number: M012
TOPCO Childrens Cough ReliefDEXTROMETHORPHAN HBR AND GUAIFENESINTopco Associates, LLCee0f5627-5104-4990-88ee-2fb46965bc1e2025-11-11WarningsExact identifier
application number: M012
TOPCARE Childrens Cold and Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDETopco Associates, LLC8931d4ca-c599-49be-87e1-8c0598f38b772025-11-11WarningsExact identifier
application number: M012
TOPCARE Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLC01c517e5-d693-4926-9eb5-4b894a2f69172025-11-11WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b4a2a-d6bf-ec25-e063-6294a90a3f062025-11-11WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435e6387-1ee0-c20f-e063-6294a90adac52025-11-11WarningsExact identifier
application number: M012
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b2025-11-10WarningsExact identifier
application number: M012
TOPCARE Childrens Allergy ChewsDIPHENHYDRAMINE HCLTopco Associates, LLCb5e15dd1-6e99-411c-9183-8a4265eae4042025-11-08WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corp103de130-ef12-4c58-bbcf-234b3f3b2cbf2025-11-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation2b3fbab9-92b5-42a7-b27b-ff46350ce0552025-11-07WarningsExact identifier
application number: M012
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp093649a4-f968-49bd-83af-bb7e0f448ecf2025-11-07WarningsExact identifier
application number: M012
TARGET Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONbfc91c71-0506-4e94-8bfe-dc9e4bf959da2025-11-07WarningsExact 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