Home NDC 63941-316-01 Allergic Itch Relief
Product NDC 63941-316
Requested package NDC 63941-316-01
11-digit product format 639410316
Labeler code 63941
Product ID 63941-316_b7162bc8-bacf-82ce-e053-2995a90adfd9
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl, Zinc acetate
Dosage form CREAM
Route TOPICAL
Labeler Valu Merchandisers, Co.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-12-01
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 2 g/100g; g/100g
NDC exclude flag No
Listing certified through 2021-12-31
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…
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 63941-316-01 Allergic Itch Relief 1 in 1 BOX CREAM 1 4 63941-316-01 Allergic Itch Relief 28 g in 1 TUBE CREAM 28 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 ZINC ACETATE ACTIVE INGREDIENT FM5526K07A ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 ZINC ACTIVE MOIETY J41CSQ7QDS ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 CARBOMER HOMOPOLYMER TYPE C INACTIVE INGREDIENT 4Q93RCW27E ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 PARAFFIN INACTIVE INGREDIENT I9O0E3H2ZE ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63941-316 ALLERGIC ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [VALU MERCHANDISERS, CO.] 4 Legacy NDC, 2 package rows 20230209_e01a4a81-d16f-484e-abfe-c39083e94a96.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 63941-316-01 63941031601 1 TUBE in 1 BOX (63941-316-01) > 28 g in 1 TUBE 1 tube 2011-12-01 0000-00-00 No No Current