FDA.reportPublic FDA data

CVS Pharmacy Pre-measured spoon Childrens

Product NDC
59779-044
11-digit product format
597790044
Labeler code
59779
Product ID
59779-044_e336231b-36c0-475c-b636-6e66af50cf05
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
CVS PHARMACY, INC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-25
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59779-044IInactivated by FDA2026-08-11
excluded packagepackage59779-04459779-044-10IInactivated by FDA2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-044-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-044-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-044-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-044-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-044-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-044-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-044-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-044-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-044-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59779-044-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59779-044-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59779-044-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59779-044-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59779-044-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59779-044-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59779-044-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59779-044-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59779-044-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59779-044-108dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59779-044-10e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59779-044-109bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59779-044-10110d247fa046…a55b01930146…

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
59779-044-102019-10-29C16284748780-1960f7f55-c77c-8e05-e053-dbdaa90a074aec5a5404-dc36-4e94-b6d9-c2ef38a2a07c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-044-10CVS Pharmacy Pre-measured spoon ChildrensALLERGY MEDICATION10 in 1 CARTONLIQUID101
59779-044-10CVS Pharmacy Pre-measured spoon ChildrensALLERGY MEDICATION5 mL in 1 POUCHLIQUID51

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
DiphenhydramineACTIVE MOIETY8GTS82S83MCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
ammonium glycyrrhizateINACTIVE INGREDIENT3VRD35U26CCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
D&C red NO. 33INACTIVE INGREDIENT9DBA0SBB0LCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
FD&C red NO. 40INACTIVE INGREDIENTWZB9127XOACVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-044CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY, INC.]1Legacy NDC, 2 package rows20110902_ec5a5404-dc36-4e94-b6d9-c2ef38a2a07c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNec5a5404-dc36-4e94-b6d9-c2ef38a2a07c1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDec5a5404-dc36-4e94-b6d9-c2ef38a2a07c1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYec5a5404-dc36-4e94-b6d9-c2ef38a2a07c1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYec5a5404-dc36-4e94-b6d9-c2ef38a2a07c1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYec5a5404-dc36-4e94-b6d9-c2ef38a2a07c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59779-044-105977900441010 in 1 CARTONHistorical