Sunmark Allergy Relief

Product NDC
49348-045
Requested package NDC
49348-045-37
11-digit product format
493480045
Labeler code
49348
Product ID
49348-045_02a343a4-0767-45e8-9c6f-095be70c5831
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-08-21
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage49348-04549348-045-37DDiscontinued by firm2026-09-14

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…

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
49348-045-342024-01-30C16284748780-11030e365-2023-111a-e063-dadaa90a10e2McKesson Allergy Relief Drug Facts
49348-045-372024-01-30C16284748780-11030e365-2023-111a-e063-dadaa90a10e2McKesson Allergy Relief Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-045-34ML - Milliliter49348-04525c60523-3968-44cd-8c9f-9373fc8118d212012-07-24
49348-045-37ML - Milliliter49348-045800c3c28-e474-4893-afb0-763455f950a312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2SUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
SORBITOLINACTIVE INGREDIENT506T60A25RSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCKESSON]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNea3ab5da-52f3-4272-b7a1-de7707c6e6883
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDea3ab5da-52f3-4272-b7a1-de7707c6e6883
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYea3ab5da-52f3-4272-b7a1-de7707c6e6883
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYea3ab5da-52f3-4272-b7a1-de7707c6e6883
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYea3ab5da-52f3-4272-b7a1-de7707c6e6883
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN77230b87-90fc-4ed6-b0ab-5671bb4f4eef1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD77230b87-90fc-4ed6-b0ab-5671bb4f4eef1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY77230b87-90fc-4ed6-b0ab-5671bb4f4eef1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY77230b87-90fc-4ed6-b0ab-5671bb4f4eef1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY77230b87-90fc-4ed6-b0ab-5671bb4f4eef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-045-37493480045371 BOTTLE in 1 CARTON (49348-045-37) > 237 mL in 1 BOTTLE1 bottle2003-08-210000-00-00NoNoCurrent