Home NDC 67510-0633-2 Anti-Itch
Product NDC 67510-0633
Requested package NDC 67510-0633-2
11-digit product format 675100633
Labeler code 67510
Product ID 67510-0633_b11f303c-fe46-1505-e053-2995a90a8fcf
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl, Zinc acetate
Dosage form CREAM
Route TOPICAL
Labeler Kareway Product, Inc.
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-12-13
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 · 9 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…
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 67510-0633-2 Anti-Itch 56.6 g in 1 TUBE CREAM 56.6 7 67510-0633-2 Anti-Itch 1 in 1 BOX CREAM 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 ZINC ACETATE ACTIVE INGREDIENT FM5526K07A ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 CARBOMER HOMOPOLYMER TYPE C INACTIVE INGREDIENT 4Q93RCW27E ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 PARAFFIN INACTIVE INGREDIENT I9O0E3H2ZE ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67510-0633 ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [KAREWAY PRODUCT, INC.] 7 Legacy NDC, 2 package rows 20230219_a3b91d7b-74a3-40ec-9228-648d491571b4.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 67510-0633-2 67510063302 1 TUBE in 1 BOX (67510-0633-2) > 56.6 g in 1 TUBE 1 tube 2013-12-13 0000-00-00 No No Current