Allergy

Product NDC
55910-091
Requested package NDC
55910-091-04
11-digit product format
559100091
Labeler code
55910
Product ID
55910-091_a6c1e37f-b80a-4ba9-ad70-4e50d9901093
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-30
Marketing end
2025-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage55910-09155910-091-04DDiscontinued by firm2026-10-12

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 · 6 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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
SUCROSEINACTIVE INGREDIENTC151H8M554ALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1
WATERINACTIVE INGREDIENT059QF0KO0RALLERGY CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-091-04559100091041 BOTTLE, PLASTIC in 1 BOX (55910-091-04) > 118 mL in 1 BOTTLE, PLASTIC2015-06-302025-01-31NoNoCurrent