Home NDC 51013-181 Nighttime SLEEP AID
Product NDC 51013-181
11-digit product format 510130181
Labeler code 51013
Product ID 51013-181_dc48a41e-2ea8-4e30-b1a9-b7b64f8082bf
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler PuraCap Pharmaceutical LLC
Application part338
Marketing category OTC MONOGRAPH FINAL
Marketing start 2016-06-27
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51013-181-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51013-181-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51013-181-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51013-181-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51013-181-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51013-181-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51013-181-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51013-181-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51013-181-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51013-181-02 Nighttime SLEEP AID 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 2 51013-181-02 Nighttime SLEEP AID 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 2 51013-181-01 Nighttime SLEEP AID 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51013-181 NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 2 Legacy NDC, 2 package rows 20191221_310f58b6-a425-4513-9c0e-5c5439ede527.zip 51013-181 NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 Legacy NDC, 1 package rows 20241130_2754748f-710b-632e-e063-6294a90a58fd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51013-181-01 51013018101 100 in 1 BOTTLE Historical 51013-181-02 51013018102 1 BLISTER PACK in 1 CARTON (51013-181-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2016-06-27 0000-00-00 No No Current