Home NDC 83154-003 ELROEL Pang Pang Sun Cushion S7
Product NDC 83154-003
11-digit product format 831540003
Labeler code 83154
Product ID 83154-003_4fa148ac-3806-aa2f-e063-6394a90af18e
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler MONOGLOT HOLDINGS Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-03
Substance TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength 1.52; 9.7; 7; 3 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ELROEL Pang Pang Sun Cushion S7
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 1.52 g/100g ZINC OXIDE 9.7 g/100g OCTINOXATE 7 g/100g OCTISALATE 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83154-003-01 ELROEL Pang Pang Sun Cushion S7 25 g in 1 CONTAINER CREAM 25 10 83154-003-02 ELROEL Pang Pang Sun Cushion S7 1 in 1 CARTON CREAM 1 10 83154-003-03 ELROEL Pang Pang Sun Cushion S7 8 g in 1 CONTAINER CREAM 8 10 83154-003-04 ELROEL Pang Pang Sun Cushion S7 1 in 1 CARTON CREAM 1 10 83154-003-05 ELROEL Pang Pang Sun Cushion S7 15 g in 1 CONTAINER CREAM 15 10 83154-003-06 ELROEL Pang Pang Sun Cushion S7 1 in 1 CARTON CREAM 1 10 83154-003-07 ELROEL Pang Pang Sun Cushion S7 25 g in 1 CONTAINER CREAM 25 10 83154-003-08 ELROEL Pang Pang Sun Cushion S7 1 in 1 POUCH CREAM 1 10 83154-003-09 ELROEL Pang Pang Sun Cushion S7 15 g in 1 CONTAINER CREAM 15 10 83154-003-10 ELROEL Pang Pang Sun Cushion S7 1 in 1 POUCH CREAM 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83154-003 ELROEL PANG PANG SUN CUSHION S7 (ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [MONOGLOT HOLDINGS INC.] 6 Current NDC, 10 package rows 20240428_256bf56f-aefa-47ce-890c-5a3896c11b92.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83154-003-01 83154000301 25 g in 1 CONTAINER 25 g Historical 83154-003-02 83154000302 1 CONTAINER in 1 CARTON (83154-003-02) / 25 g in 1 CONTAINER (83154-003-01) 1 container 2024-02-03 No No Current 83154-003-03 83154000303 8 g in 1 CONTAINER 8 g Historical 83154-003-04 83154000304 1 CONTAINER in 1 CARTON (83154-003-04) / 8 g in 1 CONTAINER (83154-003-03) 1 container 2024-02-03 No No Current 83154-003-05 83154000305 15 g in 1 CONTAINER 15 g Historical 83154-003-06 83154000306 1 CONTAINER in 1 CARTON (83154-003-06) / 15 g in 1 CONTAINER (83154-003-05) 1 container 2026-02-05 No No Current 83154-003-07 83154000307 25 g in 1 CONTAINER 25 g Historical 83154-003-08 83154000308 1 CONTAINER in 1 POUCH (83154-003-08) / 25 g in 1 CONTAINER (83154-003-07) 1 container 2026-04-16 No No Current 83154-003-09 83154000309 15 g in 1 CONTAINER 15 g Historical 83154-003-10 83154000310 1 CONTAINER in 1 POUCH (83154-003-10) / 15 g in 1 CONTAINER (83154-003-09) 1 container 2026-04-16 No No Current