FDA.reportPublic FDA data

Allergy Relief

Product NDC
49035-929
11-digit product format
490350929
Labeler code
49035
Product ID
49035-929_7eaae612-91c1-4789-a5ec-183149c2fb6e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-02
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

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, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0549035-929-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2649035-929-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3149035-929-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2849035-929-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2149035-929-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1049035-929-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3149035-929-12302b2466d912…e7b80fea0513…
2025-01-11 03:41 UTC · source 2025-01-1049035-929-510efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0849035-929-51ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0349035-929-51367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0949035-929-51557ba5c1ecfa…9c80585c8c6e…

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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
150b68ba-3ed4-4533-9118-74e76eaf6e48Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-929-12Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017
49035-929-12Allergy Relief1 in 1 CARTONTABLET, FILM COATED117
49035-929-51Allergy Relief365 in 1 BOTTLE, PLASTICTABLET, FILM COATED36517
49035-929-98Allergy Relief2 in 1 CARTONTABLET, FILM COATED217
49035-929-98Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-929-12EA - Each49035-929f1d450c6-3d47-43e9-ad96-17f5743b9eba12018-07-03
49035-929-51EA - Each49035-92903c08122-71ad-4e38-b593-57d81d43cbef12019-11-12
49035-929-98EA - Each49035-9291e9ff7d2-27b0-4b71-8b05-ee1c0fbdfb2d12023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-929ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]16Current NDC, Legacy NDC, 5 package rows20250130_150b68ba-3ed4-4533-9118-74e76eaf6e48.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 69 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Menthol Chewable GelsMENTHOLWalmart1ba4b2be-7242-0a23-e063-6294a90af29c2025-12-23WarningsExact identifier
application number: M012
Walgreens Severe Menthol Throat DropsMENTHOLWalgreens21dd3c68-cbc6-4799-e063-6394a90a69722025-12-23WarningsExact identifier
application number: M012
cherry throat relief lozengesBENZOCAINEZee Medical499d0748-538f-678c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINNuCare Pharmaceuticals, Inc.46a480c7-7092-b809-e063-6294a90a60cd2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods360a6304-206d-5475-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods36342d8c-34ab-6178-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLWinco Foods37244333-1307-5121-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco foods37718c73-880e-4a5c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco Foods40676ddc-577f-5cc9-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLWinco Foods3788e8b6-ab9e-1513-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIESeeca6370-29ea-4540-8139-e8461d58a2862025-12-23WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Martdd31f86b-f59e-459a-8e5f-176828706a4a2025-12-23WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf8e7a08e-7422-4a1b-bfec-93e0b50d10cd2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ae97-7951-4058-e053-2995a90a7b2e2025-12-23WarningsExact identifier
application number: M012
Childrens Chest Congestion Relief GrapeGUAIFENESINDiscount Drug Mart3e5d245f-515c-4106-a855-fb97681b646a2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ed16-86bb-3faf-e053-2995a90acfbc2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa7999da7-148a-4c6d-a2ea-0f4cc1d5b2832025-12-23WarningsExact identifier
application number: M012
Safetussin High Blood Pressure and diabetes Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES279e309c-040d-4001-808d-b7d986a9a1d82025-12-23WarningsExact identifier
application number: M012
Sinus PE Head Congestion and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED76fd1f8e-2670-421c-a9e6-c8adefb7962e2025-12-23WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLCardinal Health 110, LLC. DBA Leader1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e22025-12-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN150b68ba-3ed4-4533-9118-74e76eaf6e4817
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD150b68ba-3ed4-4533-9118-74e76eaf6e4817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-929-12490350929121 BOTTLE, PLASTIC in 1 CARTON (49035-929-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent
49035-929-5149035092951365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49035-929-51) 1990-03-022023-05-18NoNoCurrent
49035-929-98490350929982 BOTTLE, PLASTIC in 1 CARTON (49035-929-98) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent